A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

Phase 1

Active, not recruiting

• Conditions: Psoriatic arthritis (PsA); MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-004241-16-CZ
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-24
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 219

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
Are the trial subjects under 18? no
Number of subjects for this age range:
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 20

Exclusion Criteria

• Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use two effective methods (one of which is highly effective) of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active psoriatic arthritis (PsA).;Secondary Objective: • To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active PsA who are TNFa inhibitor naïve.<br>• To evaluate the improvement in signs and symptoms related PsA Core Domain Set in PF-06700841 treated subjects.<br>• To evaluate the improvement in patient reported outcome measures related PsA Core Domain Set in PF-06700841 treated subjects.<br>• To evaluate the improvement in additional composite outcome measures in PF-06700841 treated subjects.<br>• To evaluate the safety and tolerability of PF-06700841.;Primary end point(s): • The proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response at Week 16.;Timepoint(s) of evaluation of this end point: Week 16