A Phase 2b, multicenter, dose-ranging study to evaluate the safety and efficacy 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-BG
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-26
• Study Completion: 2021-01-15
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 218

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

• 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