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Clinical Trial Results:
A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

Summary
EudraCT number	2017-000573-37
Trial protocol	IE GB DE AT LT CZ NL SK BG GR PL BE ES PT HU EE HR IT RO
Global end of trial date	01 Jul 2021

Results information
Results version number	v1(current)
This version publication date	11 Jan 2022
First version publication date	11 Jan 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

SHP647-303

ISRCTN number

-

US NCT number

NCT03290781

WHO universal trial number (UTN)

-

Sponsor organisation name

Shire

Sponsor organisation address

300 Shire Way, Lexington, United States, MA 02421

Public contact

Study Director, Shire, ClinicalTransparency@takeda.com

Scientific contact

Study Director, Shire, ClinicalTransparency@takeda.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

01 Jul 2021

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

01 Jul 2021

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of the study was to evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of subject reported symptoms and centrally read endoscopy, in subjects with moderate to severe Ulcerative Colitis (UC).

Protection of trial subjects

This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996) and E6 R2 (2017), EU Directive 2001/20/EC, the principles of the Declaration of Helsinki, as well as other applicable national ethical and legal requirements.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

04 Apr 2018

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

30 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 4

Country: Number of subjects enrolled

Austria: 3

Country: Number of subjects enrolled

Belgium: 2

Country: Number of subjects enrolled

Bosnia and Herzegovina: 2

Country: Number of subjects enrolled

Bulgaria: 11

Country: Number of subjects enrolled

Canada: 2

Country: Number of subjects enrolled

Colombia: 2

Country: Number of subjects enrolled

Croatia: 10

Country: Number of subjects enrolled

Czechia: 12

Country: Number of subjects enrolled

Estonia: 1

Country: Number of subjects enrolled

Hungary: 16

Country: Number of subjects enrolled

Ireland: 1

Country: Number of subjects enrolled

Israel: 3

Country: Number of subjects enrolled

Italy: 14

Country: Number of subjects enrolled

Japan: 18

Country: Number of subjects enrolled

Korea, Republic of: 5

Country: Number of subjects enrolled

Lebanon: 1

Country: Number of subjects enrolled

Lithuania: 3

Country: Number of subjects enrolled

Mexico: 8

Country: Number of subjects enrolled

Netherlands: 4

Country: Number of subjects enrolled

New Zealand: 2

Country: Number of subjects enrolled

Poland: 95

Country: Number of subjects enrolled

Portugal: 8

Country: Number of subjects enrolled

Romania: 6

Country: Number of subjects enrolled

Russian Federation: 27

Country: Number of subjects enrolled

Slovakia: 9

Country: Number of subjects enrolled

South Africa: 6

Country: Number of subjects enrolled

Spain: 3

Country: Number of subjects enrolled

Ukraine: 38

Country: Number of subjects enrolled

United Kingdom: 2

Country: Number of subjects enrolled

United States: 48

Worldwide total number of subjects

366

EEA total number of subjects

198

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

5

Adults (18-64 years)

336

From 65 to 84 years

25

85 years and over

0

Subject disposition

Top of page

Recruitment details

This study was conducted at 400 sites from 4 April 2018 (first subject first visit) to 1 July 2021 (last subject last visit). A total of 366 subjects were enrolled, randomised and received study treatment.

Screening details

Subjects with moderate to severe UC who achieved a clinical response and completed their treatment period in the induction studies (either SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) were re-randomised into this study as ontamalimab and placebo responders to receive placebo or ONTA 25 milligrams (mg) or 75 mg.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Are arms mutually exclusive

Yes

ONTA 25mg/Placebo

Arm description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52 in this study.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

ONTA 25mg/ONTA 25mg

Arm description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Arm type

Experimental

Investigational medicinal product name

Ontamalimab

Investigational medicinal product code

SHP647

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

ONTA 75mg/Placebo

Arm description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

ONTA 75mg/ONTA 75mg

Arm description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Arm type

Experimental

Investigational medicinal product name

Ontamalimab

Investigational medicinal product code

SHP647

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Placebo/Placebo

Arm description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Placebo/ONTA 25mg

Arm description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Arm type

Experimental

Investigational medicinal product name

Ontamalimab

Investigational medicinal product code

SHP647

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Placebo/ONTA 75mg

Arm description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Arm type

Experimental

Investigational medicinal product name

Ontamalimab

Investigational medicinal product code

SHP647

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subject received 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Number of subjects in period 1	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg	Placebo/Placebo	Placebo/ONTA 25mg	Placebo/ONTA 75mg
Started	73	71	86	82	11	22	21
Completed	24	53	30	59	6	19	17
Not completed	49	18	56	23	5	3	4
Adverse event, serious fatal	-	-	1	-	1	-	-
Consent withdrawn by subject	6	5	9	10	1	2	-
Disease Relapse	32	5	38	7	3	1	4
Physician decision	-	1	-	-	-	-	-
Adverse event, non-fatal	5	7	4	1	-	-	-
Protocol Deviation	2	-	-	1	-	-	-
Site Terminated by Sponsor	1	-	2	1	-	-	-
Unspecified	3	-	2	2	-	-	-
Lost to follow-up	-	-	-	1	-	-	-

Baseline characteristics

Top of page

Reporting group title

ONTA 25mg/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52 in this study.

Reporting group title

ONTA 25mg/ONTA 25mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

ONTA 75mg/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

ONTA 75mg/ONTA 75mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

Placebo/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

Placebo/ONTA 25mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

Placebo/ONTA 75mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg	Placebo/Placebo	Placebo/ONTA 25mg	Placebo/ONTA 75mg	Total
Number of subjects	73	71	86	82	11	22	21
Age Categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	43.3 ( 15.40 )	41.2 ( 13.17 )	42.0 ( 13.81 )	42.3 ( 14.21 )	44.7 ( 14.16 )	40.9 ( 9.42 )	39.9 ( 12.10 )	-
Gender categorical
Units: Subjects
Female	27	29	35	35	5	9	10	150
Male	46	42	51	47	6	13	11	216
Ethnicity
Units: Subjects
Hispanic or Latino	6	6	4	7	0	3	1	27
Not Hispanic or Latino	67	64	82	74	11	19	20	337
Not Reported	0	1	0	1	0	0	0	2
Unknown	0	0	0	0	0	0	0	0
Race
Units: Subjects
American Indian or Alaska Native	2	0	1	1	0	0	0	4
Asian	5	4	5	8	1	2	3	28
Black or African American	3	1	2	2	0	0	1	9
White	58	62	77	69	10	19	17	312
Native Hawaiian or Other Pacific Islander	1	0	0	0	0	0	0	1
More than one race	4	2	0	0	0	1	0	7
Unknown or Not Reported	0	2	1	2	0	0	0	5

End points

Top of page

Reporting group title

ONTA 25mg/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52 in this study.

Reporting group title

ONTA 25mg/ONTA 25mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

ONTA 75mg/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

ONTA 75mg/ONTA 75mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

Placebo/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

Placebo/ONTA 25mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Reporting group title

Placebo/ONTA 75mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52 in this study.

Primary: Number of Subjects With Remission Based on Composite Score at Week 52

Top of page

End point title

Number of Subjects With Remission Based on Composite Score at Week 52 ^[1]

End point description

Remission: a composite score of subject reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least 1-point change from induction study baseline; rectal bleeding sub-score of 0; endoscopic sub-score of 0 or 1 (modified, excludes friability). Composite score consisted of Mayo score without Physician global assessment (PGA) sub-score and ranges from 0-9 points. Mayo score was a measure of UC disease activity ranged from 0-12 points with higher scores= severe disease and consisted of 4 sub-scores, each graded from 0-3. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). Analysis: Ontamalimab responder Full Analysis set (FAS).

End point type

Primary

End point timeframe

At Week 52

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	6	38	11	33

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.451

Confidence interval

level

95%

sides

2-sided

lower limit

0.296

upper limit

0.572

Notes
[2] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 2

Comparison groups

ONTA 75mg/Placebo v ONTA 75mg/ONTA 75mg

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[3]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.278

Confidence interval

level

95%

sides

2-sided

lower limit

0.142

upper limit

0.401

Notes
[3] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Endoscopic Remission at Week 52

Top of page

End point title

Number of Subjects With Endoscopic Remission at Week 52 ^[4]

End point description

Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration). The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 52

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	7	40	13	40

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[5]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.463

Confidence interval

level

95%

sides

2-sided

lower limit

0.31

upper limit

0.585

Notes
[5] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 2

Comparison groups

ONTA 75mg/Placebo v ONTA 75mg/ONTA 75mg

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[6]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.339

Confidence interval

level

95%

sides

2-sided

lower limit

0.197

upper limit

0.463

Notes
[6] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Clinical Remission at Week 52

Top of page

End point title

Number of Subjects With Clinical Remission at Week 52 ^[7]

End point description

Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this subject, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 52

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	13	48	19	42

Statistical Analysis 2

Comparison groups

ONTA 75mg/Placebo v ONTA 75mg/ONTA 75mg

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.294

Confidence interval

level

95%

sides

2-sided

lower limit

0.148

upper limit

0.425

Notes
[8] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[9]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.497

Confidence interval

level

95%

sides

2-sided

lower limit

0.337

upper limit

0.62

Notes
[9] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Sustained Remission at Week 52

Top of page

End point title

Number of Subjects With Sustained Remission at Week 52 ^[10]

End point description

Sustained remission was defined as in remission at Week 52 visit, among Subjects who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 52

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	4	23	7	22

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[11]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.277

Confidence interval

level

95%

sides

2-sided

lower limit

0.129

upper limit

0.398

Notes
[11] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 2

Comparison groups

ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[12]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.191

Confidence interval

level

95%

sides

2-sided

lower limit

0.067

upper limit

0.305

Notes
[12] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Clinical Response Based on Composite Score at Week 52

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End point title

Number of Subjects With Clinical Response Based on Composite Score at Week 52 ^[13]

End point description

Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease. Analysis: Ontamalimab responder FAS.

End point type

Secondary

End point timeframe

At Week 52

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	15	49	20	47

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[14]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.488

Confidence interval

level

95%

sides

2-sided

lower limit

0.329

upper limit

0.613

Notes
[14] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 2

Comparison groups

ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[15]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.343

Confidence interval

level

95%

sides

2-sided

lower limit

0.194

upper limit

0.471

Notes
[15] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52

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End point title

Number of Subjects With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52 ^[16]

End point description

Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 52

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	6	37	11	29

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[17]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.431

Confidence interval

level

95%

sides

2-sided

lower limit

0.28

upper limit

0.554

Notes
[17] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 2

Comparison groups

ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[18]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.227

Confidence interval

level

95%

sides

2-sided

lower limit

0.094

upper limit

0.349

Notes
[18] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Glucocorticoid-free Clinical Remission at Week 52

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End point title

Number of Subjects With Glucocorticoid-free Clinical Remission at Week 52 ^[19]

End point description

Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among subjects using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes). The ontamalimab responder FAS consisted of all subjects in the randomised set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 52

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	1	12	3	12

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[20]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.176

Confidence interval

level

95%

sides

2-sided

lower limit

0.049

upper limit

0.287

Notes
[20] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 2

Comparison groups

ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority ^[21]

P-value

< 0.005

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in Proportion

Point estimate

0.111

Confidence interval

level

95%

sides

2-sided

lower limit

0.006

upper limit

0.208

Notes
[21] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Glucocorticoid-free Remission at Week 52

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End point title

Number of Subjects With Glucocorticoid-free Remission at Week 52 ^[22]

End point description

Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among subjects using glucocorticoids at the baseline. Remission was defined as a composite score of subject-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). Composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. Stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Analysis was based on the ontamalimab responder FAS set.

End point type

Secondary

End point timeframe

At Week 52

Notes
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	0	8	2	10

Statistical Analysis 1

Comparison groups

ONTA 25mg/Placebo v ONTA 25mg/ONTA 25mg

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[23]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[23] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Statistical Analysis 2

Comparison groups

ONTA 75mg/ONTA 75mg v ONTA 75mg/Placebo

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005 ^[24]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[24] - P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).

Secondary: Number of Subjects With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0

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End point title

Number of Subjects With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0 ^[25]

End point description

Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this subject, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects
At Week 4	28	25	25	24
At Week 8	22	25	29	31
At Week 12	18	26	22	30
At Week 16	16	32	17	35
At Week 20	20	25	16	31
At Week 24	12	31	12	31
At Week 28	13	31	19	32
At Week 32	17	35	13	30
At Week 36	13	37	13	32
At Week 40	15	34	12	25
At Week 44	11	27	12	33
At Week 48	13	32	16	27
At Week 52	9	33	10	30

No statistical analyses for this end point

Secondary: Number of Subjects With Sustained Endoscopic Remission at Week 52

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End point title

Number of Subjects With Sustained Endoscopic Remission at Week 52 ^[26]

End point description

Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among subjects who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 52

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	4	27	8	29

No statistical analyses for this end point

Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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End point title

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

End point description

An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of subjects with TEAEs were reported. The safety set consisted of all subjects who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

From start of study drug administration up to follow-up (Week 64)

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg	Placebo/Placebo	Placebo/ONTA 25mg	Placebo/ONTA 75mg
Number of subjects analysed	73	71	86	82	11	22	21
Units: Subjects	46	41	54	51	8	11	12

No statistical analyses for this end point

Secondary: Number of Subjects who Developed Positive Antidrug Antibodies to Ontamalimab

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End point title

Number of Subjects who Developed Positive Antidrug Antibodies to Ontamalimab

End point description

Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of subjects who developed positive results for ontamalimab were reported. The safety set consisted of all subjects who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]). Here, "number of subjects analysed" signifies subjects who were evaluable for this endpoint and "n" refers to subjects who were evaluable at specific time points.

End point type

Secondary

End point timeframe

At Week 12, 24, 36 and 52

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg	Placebo/Placebo	Placebo/ONTA 25mg	Placebo/ONTA 75mg
Number of subjects analysed	72	70	81	73	11	22	21
Units: subjects
At Week 12(n=72,70,81,73,11,20,21)	7	6	8	4	2	0	4
At Week 24(n=50,61,63,71,8,22,17)	6	5	5	4	1	0	1
At Week 36(n=34,54,49,67,8,22,15)	5	3	2	4	2	1	2
At Week 52(n=25,53,31,55,7,15,16)	1	2	6	4	1	1	1

No statistical analyses for this end point

Secondary: Number of Subjects With Remission Based on Total Mayo Score at Week 52

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End point title

Number of Subjects With Remission Based on Total Mayo Score at Week 52 ^[27]

End point description

Remission defined as a total mayo score of <= 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. Total mayo score ranges from 0-12 points and consisted of the following 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0-3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0-3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0-3, where 0=normal or inactive disease; 3=severe disease. The ontamalimab responder FAS consisted of all subjects in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]).

End point type

Secondary

End point timeframe

At Week 52

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).

End point values	ONTA 25mg/Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg
Number of subjects analysed	73	71	86	82
Units: Subjects	5	38	10	33

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From start of study drug administration up to Week 64

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

ONTA 25mg/ Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Reporting group title

ONTA 25mg/ONTA 25mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 25 mg of ontamalimab were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Reporting group title

ONTA 75mg/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Reporting group title

ONTA 75mg/ONTA 75mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with 75 mg of ontamalimab were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Reporting group title

Placebo/Placebo

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Reporting group title

Placebo/ONTA 25mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Reporting group title

Placebo/ONTA 75mg

Reporting group description

Subjects who achieved a clinical response in one of the induction studies (SHP647-301 [2017-000599-27] and SHP647-302 [2017-000572-28]) with placebo were randomised to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.

Serious adverse events	ONTA 25mg/ Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg	Placebo/Placebo	Placebo/ONTA 25mg	Placebo/ONTA 75mg
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 73 (8.22%)	9 / 71 (12.68%)	9 / 86 (10.47%)	2 / 82 (2.44%)	1 / 11 (9.09%)	0 / 22 (0.00%)	2 / 21 (9.52%)
number of deaths (all causes)	0	0	1	0	1	0	0
number of deaths resulting from adverse events	0	0	1	0	1	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	1 / 82 (1.22%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Sudden cardiac death
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 1
Chest discomfort
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Drug hypersensitivity
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Pelvic pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Uterine polyp
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	1 / 21 (4.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rhinitis hypertrophic
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Clostridium test positive
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
International normalised ratio increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Radius fracture
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Joint injury
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	1 / 21 (4.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Myocardial infarction
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
Nervous system disorders
Facial paralysis
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nerve compression
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Headache
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient global amnesia
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Hypochromic anaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Iron deficiency anaemia
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis ulcerative
alternative assessment type: Systematic
subjects affected / exposed	2 / 73 (2.74%)	1 / 71 (1.41%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Large intestine perforation
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Bladder metaplasia
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Gastroenteritis
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	1 / 82 (1.22%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infectious colitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tracheobronchitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	ONTA 25mg/ Placebo	ONTA 25mg/ONTA 25mg	ONTA 75mg/Placebo	ONTA 75mg/ONTA 75mg	Placebo/Placebo	Placebo/ONTA 25mg	Placebo/ONTA 75mg
Total subjects affected by non serious adverse events
subjects affected / exposed	41 / 73 (56.16%)	27 / 71 (38.03%)	52 / 86 (60.47%)	30 / 82 (36.59%)	8 / 11 (72.73%)	11 / 22 (50.00%)	9 / 21 (42.86%)
Investigations
Weight increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	1 / 22 (4.55%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	1	0
White blood cell count decreased
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	0 / 11 (0.00%)	2 / 22 (9.09%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	4	0
Injury, poisoning and procedural complications
Contusion
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Vascular disorders
Hypertension
alternative assessment type: Systematic
subjects affected / exposed	3 / 73 (4.11%)	3 / 71 (4.23%)	0 / 86 (0.00%)	2 / 82 (2.44%)	1 / 11 (9.09%)	0 / 22 (0.00%)	1 / 21 (4.76%)
occurrences all number	3	3	0	2	1	0	1
Cardiac disorders
Arrhythmia
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Nervous system disorders
Headache
alternative assessment type: Systematic
subjects affected / exposed	4 / 73 (5.48%)	3 / 71 (4.23%)	0 / 86 (0.00%)	3 / 82 (3.66%)	1 / 11 (9.09%)	3 / 22 (13.64%)	1 / 21 (4.76%)
occurrences all number	5	4	0	3	1	7	1
Blood and lymphatic system disorders
Anaemia
alternative assessment type: Systematic
subjects affected / exposed	2 / 73 (2.74%)	4 / 71 (5.63%)	3 / 86 (3.49%)	1 / 82 (1.22%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	2	4	3	1	1	0	0
Lymphopenia
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Leukopenia
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	1 / 82 (1.22%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	1	1	1	0	0
General disorders and administration site conditions
Oedema peripheral
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	2 / 71 (2.82%)	1 / 86 (1.16%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	1	2	1	0	1	0	0
Gastrointestinal disorders
Abdominal pain
alternative assessment type: Systematic
subjects affected / exposed	3 / 73 (4.11%)	2 / 71 (2.82%)	4 / 86 (4.65%)	3 / 82 (3.66%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	3	4	4	3	1	0	0
Colitis ulcerative
subjects affected / exposed	17 / 73 (23.29%)	3 / 71 (4.23%)	29 / 86 (33.72%)	6 / 82 (7.32%)	4 / 11 (36.36%)	0 / 22 (0.00%)	1 / 21 (4.76%)
occurrences all number	17	4	35	7	4	0	1
Musculoskeletal and connective tissue disorders
Muscle spasms
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	1	2	0	0	1	0	0
Arthralgia
subjects affected / exposed	4 / 73 (5.48%)	4 / 71 (5.63%)	3 / 86 (3.49%)	3 / 82 (3.66%)	0 / 11 (0.00%)	1 / 22 (4.55%)	3 / 21 (14.29%)
occurrences all number	5	5	3	3	0	1	4
Infections and infestations
Corona virus infection
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	1 / 11 (9.09%)	1 / 22 (4.55%)	2 / 21 (9.52%)
occurrences all number	0	0	1	0	1	1	2
Nasopharyngitis
alternative assessment type: Systematic
subjects affected / exposed	4 / 73 (5.48%)	3 / 71 (4.23%)	3 / 86 (3.49%)	6 / 82 (7.32%)	2 / 11 (18.18%)	1 / 22 (4.55%)	1 / 21 (4.76%)
occurrences all number	4	4	3	7	2	1	1
Respiratory tract infection
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	0 / 71 (0.00%)	2 / 86 (2.33%)	2 / 82 (2.44%)	1 / 11 (9.09%)	1 / 22 (4.55%)	0 / 21 (0.00%)
occurrences all number	1	0	2	2	1	1	0
Upper respiratory tract infection
alternative assessment type: Systematic
subjects affected / exposed	1 / 73 (1.37%)	1 / 71 (1.41%)	4 / 86 (4.65%)	3 / 82 (3.66%)	0 / 11 (0.00%)	2 / 22 (9.09%)	0 / 21 (0.00%)
occurrences all number	1	1	4	5	0	2	0
Viral infection
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	0 / 71 (0.00%)	1 / 86 (1.16%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	1	0	1	0	0
Metabolism and nutrition disorders
Diabetes mellitus
alternative assessment type: Systematic
subjects affected / exposed	0 / 73 (0.00%)	1 / 71 (1.41%)	0 / 86 (0.00%)	0 / 82 (0.00%)	1 / 11 (9.09%)	0 / 22 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	1	0	0	1	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

11 Sep 2018

Protocol Amendment 1: - Added a statement to note that subjects who are withdrawn early from the study due to fulfilling the criteria for treatment failure also may be eligible to enter the long-term safety study, SHP647-304. - Added a statement to clarify the timing of the Week 52/ET visit (Visit 14, Part 2) for subjects who fulfilled the criteria for treatment failure and would be entering the long-term safety study. - Added new section describing benefit and risk of SHP647 treatment. - Added pregnancy to the list of reasons a subject may be withdrawn from study treatment. - Added new section describing safety monitoring and stopping algorithms for elevated hepatic blood tests.

11 Nov 2019

Protocol Amendment 2: - Updated sample size projections and power considerations to reflect a decrease in the sample size due to a reduction in the targeted power to detect an individual pairwise treatment difference at a highly statistically persuasive level (i.e., a p-value <=.001) in the primary endpoint from 90% to 85% for feasibility reasons. - Updated the text to correctly describe the scoring of subject-reported UC sign and symptom data. - Added text to indicate that adverse events of special interest will be summarized by treatment group. - Added PRO-UC daily e-diary data collection at Visit 14 (Part 2) to reflect that e-diary data were to be collected through Visit 14 (Part 2) to calculate the primary endpoint. - Revised to extend the window between the coloscopy procedure at Visit 14 (Part 1) and Visit 14 (Part 2) to 10 days, although 5 to 7 days is preferable. - Added new subsection to clarify that infectious etiology must be evaluated when a subject experiences an increase in gastrointestinal symptoms. - Added new subsection to describe classification of hypersensitivity as an adverse event of special interest. - Added language to clarify treatment failure criteria and assessment and reflect that treatment failure could be a reason for subject withdrawal. - Added that oral beclomethasone up to a maximum of 5 mg/day was permitted.

17 Sep 2020

Protocol Amendment 3: - Changed the safety follow-up period from 16 weeks to 12 weeks due to the emergent data on the half-life of ontamalimab (16 days). - Added footnote to specify that subjects performing home administrations consecutively for 3 months will need to perform liver function testing locally. - Updated to reflect the discontinuation of ontamalimab Phase 3 clinical development program as follows: - Specified that the subject’s next scheduled visit would be the Week 52/ET visit and clarified the timing of the Week 52/ET visit. - Added language to clarify that, with the early termination of the study by the sponsor, endoscopy was optional for subjects who received less than 52 weeks of treatment.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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