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Clinical Trial Results:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF ONCE DAILY ORAL ZPL-3893787-18 (30 MG) ADMINISTERED FOR 12 WEEKS IN ADULT SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS.

Summary
EudraCT number	2015-003812-19
Trial protocol	GB BG
Global end of trial date	22 Dec 2016

Results information
Results version number	v1(current)
This version publication date	06 Jan 2018
First version publication date	06 Jan 2018
Other versions

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

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Trial information

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Sponsor protocol code

ZPL389/102

ISRCTN number

US NCT number

NCT02618616

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,

Scientific contact

Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,

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

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

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

Analysis stage

Final

Date of interim/final analysis

22 Dec 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

22 Dec 2016

Was the trial ended prematurely?

Main objective of the trial

To evaluate the efficacy of an oral 30 mg dose of ZPL-3893787-18 when administered once daily, for 12 weeks, to subjects with moderate to severe plaque psoriasis.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 Jan 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 39

Country: Number of subjects enrolled

United Kingdom: 46

Country: Number of subjects enrolled

Bulgaria: 33

Country: Number of subjects enrolled

United States: 11

Worldwide total number of subjects

129

EEA total number of subjects

118

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

119

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Each subject had a screening visit to confirm suitability to enter the study, followed by 7-day run-in period.

Period 1 title

Overall Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

ZPL-389

Arm description

ZPL-3893787 30 mg once daily

Arm type

Experimental

Investigational medicinal product name

ZPL-3893787

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally OD for 12 weeks.

Placebo

Arm description

Matched placebo once daily

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.

Number of subjects in period 1	ZPL-389	Placebo
Started	87	42
Completed	66	35
Not completed	21	7
Consent withdrawn by subject	8	5
Adverse event, non-fatal	8	-
Pregnancy	-	1
Lost to follow-up	-	1
Lack of efficacy	4	-
Failure to comply with dosing & evaluations	1	-

Baseline characteristics

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Reporting group title

ZPL-389

Reporting group description

ZPL-3893787 30 mg once daily

Reporting group title

Placebo

Reporting group description

Matched placebo once daily

Reporting group values	ZPL-389	Placebo	Total
Number of subjects	87	42	129
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	79	40	119
From 65-84 years	8	2	10
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	44.5 ( 13.82 )	43.2 ( 12.64 )	-
Gender categorical
Units: Subjects
Female	33	15	48
Male	54	27	81
Body Mass Index (BMI)
Units: kg/m^2
arithmetic mean (standard deviation)	28.24 ( 3.491 )	27.86 ( 3.575 )	-

End points

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Reporting group title

ZPL-389

Reporting group description

ZPL-3893787 30 mg once daily

Reporting group title

Placebo

Reporting group description

Matched placebo once daily

Primary: Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

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End point title

Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

End point description

The PASI is an assessment routinely used for evaluating and grading the severity of psoriatic lesions and their response to therapy. PASI divides the body into 4 regions: the head, trunk, upper extremities (arms) and lower extremities (legs). Each of these areas is assessed separately for erythema, induration and scaling; these symptoms are scored on a 5-point scale from 0-4, where 0 = no symptoms and 4 = very marked. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents a reduction of at least 75% from baseline in the PASI score.

End point type

Primary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[1]	42 ^[2]
Units: scores on a scale
arithmetic mean (standard deviation)
Baseline PASI	18.96 ( 8.019 )	19.39 ( 7.898 )
Week 12 percent change from baseline	-28.043 ( 38.4436 )	-37.361 ( 32.3581 )

Notes
[1] - Full analysis set (FAS): All randomised subjects who received at least one dose of study treatment.
[2] - Full analysis set (FAS): All randomised subjects who received at least one dose of study treatment.

ANCOVA of PASI at Week 12

Comparison groups

ZPL-389 v Placebo

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.8495 ^[3]

Method

ANCOVA

Parameter type

least square difference

Point estimate

8.7

Confidence interval

level

90%

sides

1-sided

lower limit

8.4

upper limit

Notes
[3] - The 1-sided p-value tests if the ZPL-389 LS mean is < the placebo LS mean.

Secondary: PASI-50 and PASI-75 responders at Week 12

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End point title

PASI-50 and PASI-75 responders at Week 12

End point description

PASI-75 and PASI-50 are defined as a 75% and 50% reduction, respectively, from baseline in PASI score at Week 12.

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[4]	42 ^[5]
Units: Responders
number (not applicable)
PASI-50	21	15
PASI-75	12	6

Notes
[4] - FAS
[5] - FAS

Logistic Regression PASI-50

Comparison groups

ZPL-389 v Placebo

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9058

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.562

Confidence interval

level

90%

sides

2-sided

lower limit

0.27

upper limit

1.16

Logistic Regression PASI-75

Comparison groups

ZPL-389 v Placebo

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5422

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.946

Confidence interval

level

90%

sides

2-sided

lower limit

0.4

upper limit

2.25

Secondary: Improvement in Investigator Global Assessment (IGA) at Week 12

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End point title

Improvement in Investigator Global Assessment (IGA) at Week 12

End point description

An overall assessment of the severity of psoriasis was made, by the investigator, using the IGA at each visit. IGA scores take values on a 5-point scale from 0-4, where 0 = clear to 4 = severe disease. Responder is defined as a score of clear or almost clear, or a reduction of ≥2 levels. Success is defined as a score of clear or almost clear. Subjects with discontinued and missing data categories at Week 12 were considered non-responders.

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[6]	42 ^[7]
Units: Participants
number (not applicable)
Responder	10	6
Success	7	3

Notes
[6] - FAS
[7] - FAS

No statistical analyses for this end point

Secondary: Change from baseline in the NRS for pruritus (worst itch) at Week 12.

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End point title

Change from baseline in the NRS for pruritus (worst itch) at Week 12.

End point description

The pruritus NRS is an assessment tool used to assess the subject’s worst itch as a result of psoriasis in the last 12 hours. The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. They were asked the following question: On a scale of 0 (no itching) to 10 (itching as bad as you can imagine), please rate the worst itching that you felt over the last 12 hours.

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[8]	42 ^[9]
Units: Scores on a scale
arithmetic mean (standard deviation)
NRS for pruritus (worst itch) at baseline	4.89 ( 2.247 )	4.98 ( 2.742 )
Change in baseline at Week 12 (worst itch)	-1.40 ( 2.659 )	-1.78 ( 2.810 )

Notes
[8] - FAS
[9] - FAS

No statistical analyses for this end point

Secondary: Patient Global Impression of Change (PGIC) a week 12

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End point title

Patient Global Impression of Change (PGIC) a week 12

End point description

At the end of treatment (Week 12) or early termination visit, the subject was asked to rate their degree of improvement (or worsening) of their psoriasis compared to before the start of treatment with study drug, using a 7-point scale, standardized PGIC. Since the start of the study (dosing), my overall status is: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[10]	42 ^[11]
Units: Participant
number (not applicable)
Very much improved	12	3
Much improved	14	9
Minimally improved	22	11
No change	15	7
Minimally worse	5	3
Much worse	7	6
Very much worse	8	1
Missing	4	2

Notes
[10] - FAS
[11] - FAS

No statistical analyses for this end point

Secondary: Change from baseline in body surface area (BSA) and percentage change from baseline at Week 12

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End point title

Change from baseline in body surface area (BSA) and percentage change from baseline at Week 12

End point description

Assessment of the percentage of a subject’s BSA affected by psoriasis was made by best estimates of the investigator at each visit. Hand-size measurement was considered to be the “best estimate” to measure the BSA by the investigators

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[12]	42 ^[13]
Units: Area score
arithmetic mean (standard deviation)
Baseline	25.5 ( 12.60 )	27.0 ( 14.19 )
Week 12	22.7 ( 12.35 )	22.8 ( 12.77 )
Week 12 change from baseline	-2.8 ( 10.77 )	-4.2 ( 9.62 )

Notes
[12] - FAS
[13] - FAS

No statistical analyses for this end point

Secondary: Change from baseline in the daytime and night time NRS for pruritus (worst itch) at Week 12

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End point title

Change from baseline in the daytime and night time NRS for pruritus (worst itch) at Week 12

End point description

The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. They were asked the following question: On a scale of 0 (no itching) to 10 (itching as bad as you can imagine), please rate the worst itching that you felt over the last 12 hours.

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[14]	42 ^[15]
Units: Scores on a scale
arithmetic mean (standard deviation)
NRS for pruritus (daytime) at baseline	4.32 ( 2.251 )	4.52 ( 2.748 )
Change in baseline at Week 12 (daytime)	-1.40 ( 2.765 )	-1.42 ( 2.779 )
NRS for pruritus (night time) at baseline	4.19 ( 2.299 )	4.34 ( 2.682 )
Change in baseline at Week 12 (night time)	-1.35 ( 2.856 )	-1.31 ( 2.860 )

Notes
[14] - FAS n at Week 12 = 63
[15] - FAS n at Week 12 = 33

No statistical analyses for this end point

Secondary: Change from baseline in the NRS for sleep disturbance at Week 12

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End point title

Change from baseline in the NRS for sleep disturbance at Week 12

End point description

In the morning subjects were asked the following question to determine the level of sleep disturbance due to itching: On a scale of 0 (no sleep disturbance) to 10 (awake all night), please rate how much your sleep was disturbed by itch last night.

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[16]	42 ^[17]
Units: Scores on a scale
arithmetic mean (standard deviation)
NRS for pruritus (sleep disturbance) at baseline	2.48 ( 2.172 )	2.74 ( 2.559 )
Change in baseline at Week 12 (sleep disturbance)	-0.88 ( 2.417 )	-0.93 ( 2.098 )

Notes
[16] - FAS n at Week 12 = 63
[17] - FAS n at Week 12 = 33

No statistical analyses for this end point

Secondary: Change from baseline in total, daytime and night time duration of itching at Week 12

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End point title

Change from baseline in total, daytime and night time duration of itching at Week 12

End point description

Subjects were asked the following question to determine their duration of itching: Over the last 12 hours approximately how many hours, if any, did you itch?

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[18]	42 ^[19]
Units: hours
arithmetic mean (standard deviation)
Total duration of itching- Baseline	5.74 ( 4.608 )	6.68 ( 5.637 )
Total duration of itching- Change at week 12	-1.15 ( 4.525 )	-1.16 ( 5.543 )
Daytime duration of itching-Baseline	3.16 ( 2.682 )	3.57 ( 2.994 )
Daytime duration of itching-Change at week 12	-0.60 ( 2.399 )	3.63 ( 3.034 )
Night time duration of itching-Baseline	2.58 ( 2.072 )	3.11 ( 2.720 )
Night time duration of itching-Change at week 12	-0.55 ( 2.188 )	-0.43 ( 2.581 )

Notes
[18] - FAS n at Week 12 = 63
[19] - FAS n at Week 12 = 32

No statistical analyses for this end point

Secondary: Verbal Rating Scale (VRS) for pruritus at Week 12

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End point title

Verbal Rating Scale (VRS) for pruritus at Week 12

End point description

Subjects were asked to rate their itch over the last 12 hours using a list of adjectives describing different levels of symptom intensity: Over the last 12 hours how would you rate your itch? No itch; Mild; Moderate and Severe; Pruritus was evaluated by the subject, using the eDiary, twice daily for 1 week prior to the start of study treatment (run-in period) and during treatment (baseline to Day 84).

End point type

Secondary

End point timeframe

From baseline to week 12.

End point values	ZPL-389	Placebo
Number of subjects analysed	87 ^[20]	42 ^[21]
Units: Scores on a Scale
number (not applicable)
Baseline - No itch	2	2
Baseline - Mild	21	17
Baseline - Moderate	52	14
Baseline - Severe	12	9
Week 12 - No itch	17	11
Week 12 - Mild	19	10
Week 12 - Moderate	24	12
Week 12 - Severe	3	0
Missing	3	2
Discontinued	21	7

Notes
[20] - FAS
[21] - FAS

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

ZPL-389

Reporting group description

ZPL-3893787 30 mg once daily.

Reporting group title

Placebo

Reporting group description

Matched placebo once daily.

Serious adverse events	ZPL-389	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 87 (5.75%)	0 / 42 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Gastrointestinal disorders
Pancreatitis
subjects affected / exposed	1 / 87 (1.15%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 87 (1.15%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Hepatitis
subjects affected / exposed	1 / 87 (1.15%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
subjects affected / exposed	1 / 87 (1.15%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	1 / 87 (1.15%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	1 / 87 (1.15%)	0 / 42 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	ZPL-389	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	26 / 87 (29.89%)	21 / 42 (50.00%)
Nervous system disorders
Headache
subjects affected / exposed	5 / 87 (5.75%)	3 / 42 (7.14%)
occurrences all number	5	3
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	5 / 87 (5.75%)	0 / 42 (0.00%)
occurrences all number	5	0
Psoriasis
subjects affected / exposed	11 / 87 (12.64%)	1 / 42 (2.38%)
occurrences all number	11	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	5 / 87 (5.75%)	2 / 42 (4.76%)
occurrences all number	5	2

More information

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Were there any global substantial amendments to the protocol? No

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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Clinical trials

Clinical Trial Results:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF ONCE DAILY ORAL ZPL-3893787-18 (30 MG) ADMINISTERED FOR 12 WEEKS IN ADULT SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

Primary: Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

Secondary: PASI-50 and PASI-75 responders at Week 12

Secondary: PASI-50 and PASI-75 responders at Week 12

Secondary: Improvement in Investigator Global Assessment (IGA) at Week 12

Secondary: Improvement in Investigator Global Assessment (IGA) at Week 12

Secondary: Change from baseline in the NRS for pruritus (worst itch) at Week 12.

Secondary: Change from baseline in the NRS for pruritus (worst itch) at Week 12.

Secondary: Patient Global Impression of Change (PGIC) a week 12

Secondary: Patient Global Impression of Change (PGIC) a week 12

Secondary: Change from baseline in body surface area (BSA) and percentage change from baseline at Week 12

Secondary: Change from baseline in body surface area (BSA) and percentage change from baseline at Week 12

Secondary: Change from baseline in the daytime and night time NRS for pruritus (worst itch) at Week 12

Secondary: Change from baseline in the daytime and night time NRS for pruritus (worst itch) at Week 12

Secondary: Change from baseline in the NRS for sleep disturbance at Week 12

Secondary: Change from baseline in the NRS for sleep disturbance at Week 12

Secondary: Change from baseline in total, daytime and night time duration of itching at Week 12

Secondary: Change from baseline in total, daytime and night time duration of itching at Week 12

Secondary: Verbal Rating Scale (VRS) for pruritus at Week 12

Secondary: Verbal Rating Scale (VRS) for pruritus at Week 12

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Estonia
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Germany
Greece
Hungary
Iceland
Ireland
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Malta
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United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF ONCE DAILY ORAL ZPL-3893787-18 (30 MG) ADMINISTERED FOR 12 WEEKS IN ADULT SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

Primary: Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

Secondary: PASI-50 and PASI-75 responders at Week 12

Secondary: PASI-50 and PASI-75 responders at Week 12

Secondary: Improvement in Investigator Global Assessment (IGA) at Week 12

Secondary: Improvement in Investigator Global Assessment (IGA) at Week 12

Secondary: Change from baseline in the NRS for pruritus (worst itch) at Week 12.

Secondary: Change from baseline in the NRS for pruritus (worst itch) at Week 12.

Secondary: Patient Global Impression of Change (PGIC) a week 12

Secondary: Patient Global Impression of Change (PGIC) a week 12

Secondary: Change from baseline in body surface area (BSA) and percentage change from baseline at Week 12

Secondary: Change from baseline in body surface area (BSA) and percentage change from baseline at Week 12

Secondary: Change from baseline in the daytime and night time NRS for pruritus (worst itch) at Week 12

Secondary: Change from baseline in the daytime and night time NRS for pruritus (worst itch) at Week 12

Secondary: Change from baseline in the NRS for sleep disturbance at Week 12

Secondary: Change from baseline in the NRS for sleep disturbance at Week 12

Secondary: Change from baseline in total, daytime and night time duration of itching at Week 12

Secondary: Change from baseline in total, daytime and night time duration of itching at Week 12

Secondary: Verbal Rating Scale (VRS) for pruritus at Week 12

Secondary: Verbal Rating Scale (VRS) for pruritus at Week 12

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF ONCE DAILY ORAL ZPL-3893787-18 (30 MG) ADMINISTERED FOR 12 WEEKS IN ADULT SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS.