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Clinical Trial Results:
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy and Safety Profile of PF-06700841 in Participants With Active Systemic Lupus Erythematosus (SLE)

Summary
EudraCT number	2018-004175-12
Trial protocol	BE HU GB CZ RO BG PT DE PL ES IT
Global end of trial date	05 Oct 2023

Results information
Results version number	v1(current)
This version publication date	14 Jul 2024
First version publication date	14 Jul 2024
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

B7931028

ISRCTN number

-

US NCT number

NCT03845517

WHO universal trial number (UTN)

-

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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

26 Apr 2024

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

05 Oct 2023

Was the trial ended prematurely?

No

Main objective of the trial

To evaluate the efficacy of 3 once daily (QD) dose levels of PF-06700841 compared to placebo in participants with active SLE.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

18 Apr 2019

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 4

Country: Number of subjects enrolled

Canada: 3

Country: Number of subjects enrolled

Czechia: 6

Country: Number of subjects enrolled

Germany: 1

Country: Number of subjects enrolled

France: 2

Country: Number of subjects enrolled

Hungary: 10

Country: Number of subjects enrolled

Japan: 19

Country: Number of subjects enrolled

Belgium: 3

Country: Number of subjects enrolled

Spain: 8

Country: Number of subjects enrolled

China: 4

Country: Number of subjects enrolled

Portugal: 1

Country: Number of subjects enrolled

Bulgaria: 25

Country: Number of subjects enrolled

Colombia: 24

Country: Number of subjects enrolled

Korea, Republic of: 5

Country: Number of subjects enrolled

Poland: 25

Country: Number of subjects enrolled

Serbia: 19

Country: Number of subjects enrolled

Romania: 11

Country: Number of subjects enrolled

Taiwan: 17

Country: Number of subjects enrolled

Ukraine: 33

Country: Number of subjects enrolled

United Kingdom: 5

Country: Number of subjects enrolled

Mexico: 51

Country: Number of subjects enrolled

United States: 70

Country: Number of subjects enrolled

Greece: 4

Worldwide total number of subjects

350

EEA total number of subjects

96

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)

0

Adults (18-64 years)

341

From 65 to 84 years

9

85 years and over

0

Subject disposition

Top of page

Recruitment details

A total of 350 participants with active SLE were enrolled and randomized in the study.

Screening details

The study was conducted at approximately 185 sites in the 24 countries from 18 April 2019 to 05 October 2023.

Period 1 title

Treatment Period (TP) (52 Weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants were randomised to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received placebo matched to PF-06700841 QD for 52 weeks.

PF-06700841 15 mg

Arm description

Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received PF-06700841 15 mg QD for 52 weeks.

PF-06700841 30 mg

Arm description

Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received PF-06700841 30 mg QD for 52 weeks.

PF-06700841 45 mg

Arm description

Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received PF-06700841 45 mg QD for 52 weeks.

Number of subjects in period 1	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Started	100	50	101	99
Completed	68	36	78	71
Not completed	32	14	23	28
Consent withdrawn by subject	4	6	6	5
Adverse event, non-fatal	12	7	10	17
Death	-	-	1	-
Pregnancy	1	-	-	1
Non-compliance with study drug	1	-	-	-
Site Terminated by Sponsor	2	-	-	-
Unspecified	2	-	-	-
Lost to follow-up	2	-	1	-
Lack of efficacy	8	1	3	4
Physician's decision	-	-	1	-
Protocol deviation	-	-	1	1

Period 2 title

Follow-up Period (FU P) (4 Weeks)

Is this the baseline period?

No

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

No

Placebo

Arm description

Participants were randomised to receive placebo matched to PF-06700841 once daily (QD) for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received placebo matched to PF-06700841 QD for 52 weeks.

PF-06700841 15 mg

Arm description

Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received PF-06700841 15 mg QD for 52 weeks.

PF-06700841 30 mg

Arm description

Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received PF-06700841 30 mg QD for 52 weeks.

PF-06700841 45 mg

Arm description

Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received PF-06700841 45 mg QD for 52 weeks.

Number of subjects in period 2	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Started	68	36	78	71
Completed	89	42	89	92
Not completed	11	8	12	7
Consent withdrawn by subject	3	5	7	1
Adverse event, non-fatal	4	2	-	2
Death	-	-	1	1
Pregnancy	1	-	-	-
Study terminated by sponsor	-	-	-	1
Unspecified	1	-	1	-
Lost to follow-up	2	1	2	-
Physician's decision	-	-	1	1
Protocol deviation	-	-	-	1
Joined	32	14	23	28
Continue to follow up	32	14	23	28

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Participants were randomised to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 15 mg

Reporting group description

Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 30 mg

Reporting group description

Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 45 mg

Reporting group description

Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg	Total
Number of subjects	100	50	101	99	350
Age categorical
Units: Participants
Adults (18-64 years)	100	49	97	95	341
From 65-84 years	0	1	4	4	9
Age Continuous
Units: Years
arithmetic mean (standard deviation)	42.5 ( 9.60 )	41.5 ( 11.79 )	42.8 ( 12.71 )	41.0 ( 11.47 )	-
Sex: Female, Male
Units: Participants
Female	94	45	97	91	327
Male	6	5	4	8	23
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	2	0	7	2	11
Asian	14	9	11	13	47
Black or African American	6	4	6	7	23
White	71	31	69	68	239
More than one race	2	0	0	0	2
Unknown or Not Reported	5	6	8	9	28
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	29	17	34	35	115
Not Hispanic or Latino	71	32	67	62	232
Unknown or Not Reported	0	1	0	2	3

End points

Top of page

Reporting group title

Placebo

Reporting group description

Participants were randomised to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 15 mg

Reporting group description

Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 30 mg

Reporting group description

Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 45 mg

Reporting group description

Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

Placebo

Reporting group description

Participants were randomised to receive placebo matched to PF-06700841 once daily (QD) for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 15 mg

Reporting group description

Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 30 mg

Reporting group description

Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 45 mg

Reporting group description

Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Primary: Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52

Top of page

End point title

Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52

End point description

SRI-4 components: SLEDAI-2K,BILAG 2004 and PhGA. Participants were classified as SRI-4 responders, if they met all of criteria compared with baseline:1)>= 4 point reduction in SLEDAI-2K score; 2)no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3)no worsening < 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). Full analysis set (FAS):all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here “Number of Subjects Analyzed” signifies participants at Week 52 with Non-Responder Imputation (NRI) and Last Observation Carried Forward from Week 48 (LOCF48) applied.

End point type

Primary

End point timeframe

Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	96	47	99	92
Units: Percentage of participants
number (confidence interval 95%)	64.6 (54.5 to 74.7)	57.4 (42.2 to 72.6)	69.7 (60.1 to 79.3)	66.3 (56.1 to 76.5)

Placebo versus PF-06700841 15 mg

Comparison groups

Placebo v PF-06700841 15 mg

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.8076 ^[1]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

-7.5

Confidence interval

level

95%

sides

2-sided

lower limit

-24.5

upper limit

9.5

Notes
[1] - One sided p-value.

Placebo versus PF-06700841 45 mg

Comparison groups

PF-06700841 45 mg v Placebo

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.401 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-11.8

upper limit

15.3

Notes
[2] - One sided p-value.

Placebo versus PF-06700841 30 mg

Comparison groups

PF-06700841 30 mg v Placebo

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.2189 ^[3]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

5.2

Confidence interval

level

95%

sides

2-sided

lower limit

-7.9

upper limit

18.3

Notes
[3] - One sided p-value.

Secondary: Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52

Top of page

End point title

Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52

End point description

BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). FAS was included. Here “Number of Subjects Analyzed” signifies participants at Week 52 with NRI and LOCF48 applied.

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	96	47	99	92
Units: Percentage of participants
number (confidence interval 95%)	43.8 (33.3 to 54.2)	42.6 (27.4 to 57.8)	52.5 (42.2 to 62.9)	53.3 (42.5 to 64.0)

Placebo versus PF-06700841 15 mg

Comparison groups

Placebo v PF-06700841 15 mg

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

P-value

< 0.595 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

-2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-19.1

upper limit

14.9

Notes
[4] - One sided p-value.

Placebo versus PF-06700841 30 mg

Comparison groups

Placebo v PF-06700841 30 mg

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

P-value

< 0.1125 ^[5]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

8.6

Confidence interval

level

95%

sides

2-sided

lower limit

-5.3

upper limit

22.6

Notes
[5] - One sided p-value.

Placebo versus PF-06700841 45 mg

Comparison groups

Placebo v PF-06700841 45 mg

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0891 ^[6]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

9.6

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

23.6

Notes
[6] - One sided p-value.

Secondary: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52

Top of page

End point title

Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52

End point description

LLDAS was defined as SLE disease activity index (SLEDAI-2k <=4, with no activity in major organ systems [renal, central nervous system, cardiopulmonary, vasculitis, fever]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) <=1; a current prednisolone (or equivalent) dose <=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Data from participants from few sites were excluded from FAS. Here “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	93	47	97	88
Units: Percentage of participants
number (confidence interval 95%)	22.6 (13.5 to 31.6)	21.3 (8.5 to 34.0)	35.1 (25.0 to 45.1)	34.1 (23.6 to 44.6)

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline

Top of page

End point title

Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline

End point description

In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to <=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52). FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent >7.5 mg/day were analyzed. Here, “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.

End point type

Secondary

End point timeframe

Week 52 for achieving reduction in dose along with Week 42 to Week 52 for sustained dosing

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	53	33	46	43
Units: Percentage of participants
number (confidence interval 95%)	26.4 (13.6 to 39.2)	36.4 (18.4 to 54.3)	37.0 (21.9 to 52.0)	41.9 (26.0 to 57.8)

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline

Top of page

End point title

Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline

End point description

In this outcome measure data is reported for participants who achieved a reduction a SRI-4 response with prednisone dose reduced to <=7.5 mg/day and sustained for 12 weeks at Week 52. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent >7.5 mg/day were analyzed. Here, “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.

End point type

Secondary

End point timeframe

12 Weeks prior at Week 52 (Week 40 to Week 52)

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	53	33	46	43
Units: Percentage of participants
number (confidence interval 95%)	20.8 (8.9 to 32.6)	30.3 (13.1 to 47.5)	32.6 (18.0 to 47.2)	32.6 (17.4 to 47.7)

No statistical analyses for this end point

Secondary: Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10

Top of page

End point title

Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10

End point description

CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70). FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline CLASI-A score >= 10 were analyzed. Here, “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	23	12	27	16
Units: Percentage of participants
number (confidence interval 95%)	73.9 (53.8 to 94.0)	58.3 (26.3 to 90.4)	77.8 (60.2 to 95.3)	56.3 (28.8 to 83.7)

No statistical analyses for this end point

Secondary: Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52

Top of page

End point title

Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	66	36	75	64
Units: Units on a scale
least squares mean (confidence interval 95%)	11.585 (7.475 to 15.695)	10.892 (5.241 to 16.544)	12.371 (8.464 to 16.278)	14.875 (10.748 to 19.002)

No statistical analyses for this end point

Secondary: Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52

Top of page

End point title

Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52

End point description

The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable with observed data at Week 52.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	66	36	75	64
Units: Units on a scale
least squares mean (confidence interval 95%)	4.6 (2.5 to 6.6)	7.4 (4.5 to 10.2)	5.8 (3.8 to 7.8)	7.6 (5.5 to 9.7)

No statistical analyses for this end point

Secondary: Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52

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End point title

Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	62	32	66	50
Units: Units on a scale
least squares mean (confidence interval 95%)	9.207 (4.352 to 14.062)	10.935 (4.070 to 17.799)	8.169 (3.448 to 12.890)	15.599 (10.355 to 20.843)

No statistical analyses for this end point

Secondary: Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52

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End point title

Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	66	36	75	64
Units: Units on a scale
least squares mean (confidence interval 95%)	8.113 (4.132 to 12.093)	10.469 (4.968 to 15.969)	7.547 (3.749 to 11.346)	11.823 (7.806 to 15.840)

No statistical analyses for this end point

Secondary: Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52

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End point title

Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	66	36	75	64
Units: Units on a scale
least squares mean (confidence interval 95%)	10.317 (5.951 to 14.683)	11.893 (5.892 to 17.894)	11.701 (7.550 to 15.853)	16.443 (12.036 to 20.850)

No statistical analyses for this end point

Secondary: Change From Baseline in Pain Domain Scores of LupusQoL at Week 52

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End point title

Change From Baseline in Pain Domain Scores of LupusQoL at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	66	36	75	64
Units: Units on a scale
least squares mean (confidence interval 95%)	15.065 (10.470 to 19.659)	15.480 (9.132 to 21.828)	16.855 (12.488 to 21.223)	24.418 (19.790 to 29.047)

No statistical analyses for this end point

Secondary: Change From Baseline in Planning Domain Scores of LupusQoL at Week 52

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End point title

Change From Baseline in Planning Domain Scores of LupusQoL at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	66	36	75	64
Units: Units on a scale
least squares mean (confidence interval 95%)	14.168 (9.423 to 18.912)	12.013 (5.487 to 18.538)	10.335 (5.826 to 14.843)	20.310 (15.523 to 25.097)

No statistical analyses for this end point

Secondary: Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52

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End point title

Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	66	36	75	64
Units: Units on a scale
least squares mean (confidence interval 95%)	12.535 (7.227 to 17.842)	17.739 (10.412 to 25.065)	11.560 (6.500 to 16.621)	18.878 (13.523 to 24.233)

No statistical analyses for this end point

Secondary: Incidence Rate of Severe Flare Event

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End point title

Incidence Rate of Severe Flare Event

End point description

Incidence rate was defined as the number of participants with events per 100 participant-years. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	96	47	100	97
Units: Participants per 100 participant-years
number (confidence interval 95%)	8.32 (3.35 to 17.15)	6.92 (1.43 to 20.23)	3.24 (0.67 to 9.46)	6.95 (2.55 to 15.13)

No statistical analyses for this end point

Secondary: Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52

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End point title

Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52

End point description

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	56	25	59	42
Units: Units on a scale
least squares mean (confidence interval 95%)	12.430 (6.842 to 18.019)	12.625 (4.112 to 21.139)	6.494 (0.960 to 12.027)	15.363 (9.078 to 21.647)

No statistical analyses for this end point

Secondary: Number of Participants With Treatment-Emergent Adverse Events (AE)

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End point title

Number of Participants With Treatment-Emergent Adverse Events (AE)

End point description

An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	100	50	101	99
Units: Participants	80	38	88	83

No statistical analyses for this end point

Secondary: Number of Participants With Serious Adverse Events (SAEs)

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End point title

Number of Participants With Serious Adverse Events (SAEs)

End point description

An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	100	50	101	99
Units: Participants	8	4	8	9

No statistical analyses for this end point

Secondary: Number of Participants With Adverse Events Leading to Discontinuation From Study

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End point title

Number of Participants With Adverse Events Leading to Discontinuation From Study

End point description

An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this endpoint, participants with adverse events leading to discontinuation from study were reported. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	100	50	101	99
Units: Participants	6	2	1	3

No statistical analyses for this end point

Secondary: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

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End point title

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

End point description

Clinical significance in ECG abnormalities was judged by investigator. Safety analysis set (SAS) included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	100	50	101	99
Units: Participants	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Participants With Clinically Significant Vital Signs Abnormalities

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End point title

Number of Participants With Clinically Significant Vital Signs Abnormalities

End point description

Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Secondary

End point timeframe

Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	100	50	101	99
Units: Participants	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Participants With Laboratory Test Abnormalities

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End point title

Number of Participants With Laboratory Test Abnormalities

End point description

Hematology (Hemoglobin[hgb],hematocrit,erythrocytes[ery]:<0.8*lower limit of normal[LLN];reticulocytes,reticulocytes/ery:<0.5*LLN,>1.5*upper LN[ULN];ery mean corpuscular volume[EMC], EMC hgb:<0.9*LLN,>1.5*ULN;EMC hgb concentration:<0.9* LLN;platelet:<0.5*LLN;leukocytes[leu]:<0.6*LLN,>1.5*ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:<0.8* LLN,>1.2*ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:>1.2*ULN;activated partial thromboplastin time[PTT], PTT, prothrombin time:>1.1*ULN);Clinical chemistry(Total/direct/indirect bilirubin, glucose-fasting:>1.5*ULN; aspartate aminotransferase[AT], alanine AT:>3.0*ULN; protein, albumin, HDL cholesterol:<0.8*LLN;urea nitrogen, creatinine, triglyceride, cholesterol:>1.3*ULN;urate,LDL cholesterol:>1.2*ULN;potassium:<0.9*LLN,>1.1*ULN;calcium, bicarbonate:<0.9*LLN;creatine kinase:>2.0*ULN);Urinalysis (pH<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:>1).SAS.

End point type

Secondary

End point timeframe

Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)

End point values	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Number of subjects analysed	100	50	101	99
Units: Participants	96	48	99	97

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)

Adverse event reporting additional description

Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorised as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Placebo

Reporting group description

Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 30 mg

Reporting group description

Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 45 mg

Reporting group description

Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 15 mg

Reporting group description

Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

Serious adverse events	Placebo	PF-06700841 30 mg	PF-06700841 45 mg	PF-06700841 15 mg
Total subjects affected by serious adverse events
subjects affected / exposed	8 / 100 (8.00%)	8 / 101 (7.92%)	9 / 99 (9.09%)	4 / 50 (8.00%)
number of deaths (all causes)	0	1	1	0
number of deaths resulting from adverse events	0	1	1	0
Investigations
Transaminases increased
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cutaneous T-cell lymphoma
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Circulatory collapse
subjects affected / exposed	0 / 100 (0.00%)	1 / 101 (0.99%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Nervous system disorders
Lupus encephalitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Thalamic stroke
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Non-cardiac chest pain
subjects affected / exposed	0 / 100 (0.00%)	1 / 101 (0.99%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 100 (0.00%)	1 / 101 (0.99%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Intestinal strangulation
subjects affected / exposed	0 / 100 (0.00%)	1 / 101 (0.99%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	1 / 100 (1.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Lupus pleurisy
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 100 (1.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Ureterolithiasis
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 100 (1.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lupus nephritis
subjects affected / exposed	1 / 100 (1.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
subjects affected / exposed	2 / 100 (2.00%)	1 / 101 (0.99%)	2 / 99 (2.02%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 1	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 100 (0.00%)	1 / 101 (0.99%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bacteraemia
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 100 (0.00%)	1 / 101 (0.99%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 100 (1.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 100 (0.00%)	1 / 101 (0.99%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	1 / 100 (1.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	0 / 99 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	1 / 99 (1.01%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo	PF-06700841 30 mg	PF-06700841 45 mg	PF-06700841 15 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	47 / 100 (47.00%)	53 / 101 (52.48%)	47 / 99 (47.47%)	19 / 50 (38.00%)
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 100 (1.00%)	1 / 101 (0.99%)	4 / 99 (4.04%)	3 / 50 (6.00%)
occurrences all number	1	1	5	3
Nervous system disorders
Headache
subjects affected / exposed	5 / 100 (5.00%)	17 / 101 (16.83%)	9 / 99 (9.09%)	4 / 50 (8.00%)
occurrences all number	6	20	9	5
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 100 (0.00%)	6 / 101 (5.94%)	2 / 99 (2.02%)	0 / 50 (0.00%)
occurrences all number	0	6	2	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	5 / 100 (5.00%)	7 / 101 (6.93%)	6 / 99 (6.06%)	1 / 50 (2.00%)
occurrences all number	5	11	6	1
Nausea
subjects affected / exposed	5 / 100 (5.00%)	3 / 101 (2.97%)	7 / 99 (7.07%)	4 / 50 (8.00%)
occurrences all number	5	3	9	4
Vomiting
subjects affected / exposed	1 / 100 (1.00%)	4 / 101 (3.96%)	4 / 99 (4.04%)	3 / 50 (6.00%)
occurrences all number	1	4	4	3
Infections and infestations
Cystitis
subjects affected / exposed	3 / 100 (3.00%)	2 / 101 (1.98%)	2 / 99 (2.02%)	3 / 50 (6.00%)
occurrences all number	3	2	3	8
Nasopharyngitis
subjects affected / exposed	7 / 100 (7.00%)	6 / 101 (5.94%)	8 / 99 (8.08%)	5 / 50 (10.00%)
occurrences all number	10	8	9	5
Oral candidiasis
subjects affected / exposed	0 / 100 (0.00%)	0 / 101 (0.00%)	6 / 99 (6.06%)	0 / 50 (0.00%)
occurrences all number	0	0	7	0
Upper respiratory tract infection
subjects affected / exposed	7 / 100 (7.00%)	11 / 101 (10.89%)	8 / 99 (8.08%)	1 / 50 (2.00%)
occurrences all number	7	12	11	1
Urinary tract infection
subjects affected / exposed	11 / 100 (11.00%)	10 / 101 (9.90%)	11 / 99 (11.11%)	1 / 50 (2.00%)
occurrences all number	13	11	12	2
COVID-19
subjects affected / exposed	17 / 100 (17.00%)	11 / 101 (10.89%)	10 / 99 (10.10%)	9 / 50 (18.00%)
occurrences all number	17	11	10	10

More information

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Were there any global substantial amendments to the protocol? Yes

02 Mar 2021

The following modifications were made to PA4 as a result of the updated PF-06700841 Investigational Brochure (IB). The following changes were added and/or modified to the overview of the MoA and the safety profile of the product: Section 2.2.2. Clinical Overview Added study C2501007, an ongoing study in hidradenitis suppurativa. Updated to include additional guidance to the sites to encourage randomized participants to remain in the study at least through to the end of the double-blind period to complete safety and efficacy assessments.

28 Sep 2021

The overall rationale for B7931028 protocol amendment 6 is to address the Quantiferon gold test results which are not negative. The amendment will allow specific safety monitoring to be put into place to allow participants with latent TB (not active TB) to be eligible for the B7931028 study provided the protocol criteria can be met. China is having the biggest impact on enrolling participants into the study because of this eligibility criteria; however, once the next global protocol amendment is required, this language will be added as well.

06 Jun 2022

The overall rationale for B7931028 Protocol Amendment 7 is to decrease the sample size for the study from 448 participants to 350 participants, and to allow eligibility of participants with latent TB (positive quantiferon gold tests) who agree to receiving treatment with INH and Vitamin B6. This amendment also included the administrative changes made in Protocol Amendment 5 (requested during the EU Voluntary Harmonization Procedure (VHP) review of Amendment 4, countries submitting their initial clinical trial application with Amendment 5 (Italy and Argentina), and to any country requiring new protocol amendments to be submitted (Taiwan); and Protocol Amendment 6 (China only amendment) to be globally implemented. Furthermore, this change will allow specific safety monitoring to be put into place to allow participants with latent TB (not active TB) to be eligible for the study provided the protocol inclusion/exclusion criteria can be met.

15 Jun 2023

The driver for B7931028 Protocol Amendment 8 is to modify the key secondary endpoint of ‘time to first severe SLE flare’ and replace it with an exploratory endpoint of ‘BICLA response at Week 52’. ‘ Time to first severe SLE flare’ will remain as a secondary endpoint, just not the ‘key’ secondary endpoint and the data will be summarized as a secondary endpoint. The estimands for the associated endpoints have been updated to reflect these changes. E2, has been updated to align with the revised ‘Key’ secondary endpoint of ‘BICLA response at Week 52’ as was E7, the estimand for 'time to first severe SLE flare’.

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.

For the PF-06700841 30 mg, there was a total of 1 death which was reported in both on-treatment and follow-up phases in subject disposition section.

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