Clinical Trials Register

Summary
EudraCT Number:	2018-004241-16
Sponsor's Protocol Code Number:	B7931030
National Competent Authority:	Bulgarian Drug Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-06-26
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Bulgarian Drug Agency

A.2

EudraCT number

2018-004241-16

A.3

Full title of the trial

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS

ФАЗА 2Б, РАНДОМИЗИРАНО, ДВОЙНО СЛЯПО, ПЛАЦЕБО КОНТРОЛИРАНО ПРОУЧВАНЕ НА PF 06700841 ЗА ОЦЕНКА НА ЕФИКАСНОСТТА СЛЕД 16 СЕДМИЦИ И ЗА ОЦЕНКА НА БЕЗОПАСНОСТТА И ЕФИКАСНОСТТА ДО 1 ГОДИНА ПРИ УЧАСТНИЦИ С АКТИВЕН ПСОРИАТИЧЕН АРТРИТ

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Phase 2b, multicenter, dose-ranging study to evaluate the safety and efficacy of PF-06700841 in subjects with active psoriatic arthritis.

Фаза 2b, многоцентрово, с подбор на дозата проучване за оценка на безопасността и ефикасността на PF-06700841 при участници с активен псориатричен артрит.

A.4.1

Sponsor's protocol code number

B7931030

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+18007181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PF-06700841
D.3.2	Product code	PF-06700841 5mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PF-06700841
D.3.9.2	Current sponsor code	PF-06700841
D.3.9.3	Other descriptive name	PF-06700841-15
D.3.9.4	EV Substance Code	SUB184971
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PF-06700841
D.3.2	Product code	PF-06700841 25mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PF-06700841
D.3.9.2	Current sponsor code	PF-06700841
D.3.9.3	Other descriptive name	PF-06700841-15
D.3.9.4	EV Substance Code	SUB184971
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriatic arthritis (PsA)

E.1.1.1

Medical condition in easily understood language

Psoriatic arthritis (PsA) is a chronic inflammatory disease

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active psoriatic arthritis (PsA).

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active PsA who are TNFα inhibitor naïve.
• To evaluate the improvement in signs and symptoms related PsA Core Domain Set in PF-06700841 treated subjects.
• To evaluate the improvement in patient reported outcome measures related PsA Core Domain Set in PF-06700841 treated subjects.
• To evaluate the improvement in additional composite outcome measures in PF-06700841 treated subjects.
• To evaluate the safety and tolerability of PF-06700841.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or female subjects between 18-75 years of age, inclusive, at time of informed consent.
• To meet the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria, a subject must have inflammatory articular disease with at least 3 points from the 5 categories, please see the categories description in protocol.
• The subject must have evidence of active arthritis as defined by having at least 3 tender/painful joints on motion and at least 3 swollen joints at both Screening and Baseline.
• The subject must have diagnosed active plaque psoriasis, with at least one psoriatic plaque or nail changes consistent with psoriasis, at both Screening and Baseline.
• Ongoing treatment with a single non-biologic DMARD (limited to methotrexate, leflunomide, sulfasalazine) during the study is allowed but is not required. Other non-biologic DMARD must be discontinued.
• Subjects who have received TNF inhibiting biologic agent must have experienced an inadequate response. Subjects could have failed no more than one TNF inhibiting biologic agent.

See section 4.1 of the Protocol for a full list of Inclusion Criteria

E.4

Principal exclusion criteria

• History of infection needing hospitalization or treatment detailed in protocol or history of an infected joint prosthesis. Any known current chronic infection or recurrent infection.
• Subjects who have undergone treatment with any IL-17 inhibitor, IL-12/23 inhibitor, or IL-23 inhibitor.
• Subjects who have undergone treatment with any Janus kinase (Jak) inhibitors, (including but not limited to tofacitinib [Xeljanz], baricitinib [Olumiant], upadacitinib, peficitinib, filgotinib).

See section 4.2 of the Protocol for a full list of Exclusion Criteria

E.5 End points

E.5.1

Primary end point(s)

• The proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response at Week 16.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

E.5.2

Secondary end point(s)

Week 16:
• The proportion of subjects achieving an ACR20 response at Week 16 in the subgroup of subjects who are TNFα inhibitor naïve.

Assessed at all treatment timepoints:
• The proportion of subjects achieving an ACR20 response at all treatment timepoints (other than Week 16), and proportion of subjects achieving an ACR50 and ACR70 response;
• Change from baseline in the ACR response criteria components (Tender/painful joint count, Swollen joint count, Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, Health Assessment Questionnaire [HAQ] disability index [DI], and hsCRP);
• The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 (PASI75/90/100) response;
• Change from baseline in the enthesitis score (using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index and Leeds Enthesitis Index);
• Change from baseline in the Dactylitis Severity Score;
• Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score.
• Change from baseline in the Patient’s Global Joint and Skin Assessment Visual Analog Scale (PGJS-VAS);
• Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue);

Assessed at all treatment timepoints except Week 2:
• Change from baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute.
• The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) response;
• Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA);
• The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC);
• Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS).

Throughout the study:
• Incidence of adverse events (AEs), serious adverse events (SAEs) and serious infectious events (SIEs), withdrawals due to AEs and SAEs, and laboratory abnormalities, changes in vital signs, and electrocardiogram (ECG) findings throughout the study.

E.5.2.1

Timepoint(s) of evaluation of this end point

Individual timepoints are included in each bullet point above.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Belarus

Bulgaria

Czech Republic

Estonia

Hungary

Lithuania

Poland

Russian Federation

Serbia

Slovakia

Spain

Ukraine

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

176

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

125

F.4.2.2

In the whole clinical trial

196

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-08-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-01-15

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