Psoriasis Clinical Trial

A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis

Summary

This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) >=3 out of 78 and swollen joint count (SJC) >=3 out of 76
Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline
Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit
Subjects taking methotrexate (MTX) (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
Subjects taking leflunomide (LEF; <=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16

Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:

experienced an inadequate response to previous treatment given for at least 3 months
been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
lost access to TNF inhibitor for other reasons

Exclusion Criteria:

Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline
Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis

Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:

<= 3 excised or ablated basal cell carcinomas of the skin
One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
Actinic keratosis (-es)
Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

206

Study ID:

NCT02969525

Recruitment Status:

Completed

Sponsor:

UCB Biopharma S.P.R.L.

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There are 13 Locations for this study

See Locations Near You

Pa0008 007
San Diego California, 92037, United States
Pa0008 005
Aventura Florida, 33180, United States
Pa0008 003
Hagerstown Maryland, 21740, United States
Pa0008 011
Lansing Minnesota, 48910, United States
Pa0008 025
Lexington New York, 40504, United States
Pa0008 014
Portland Oregon, 97239, United States
Pa0008 001
Duncansville Pennsylvania, 16635, United States
Pa0008 012
Johnston Rhode Island, 02919, United States
Pa0008 004
Charleston South Carolina, 29406, United States
Pa0008 010
Jackson Tennessee, 38305, United States
Pa0008 006
Dallas Texas, 75231, United States
Pa0008 013
Mesquite Texas, 75150, United States
Pa0008 002
Seattle Washington, 98122, United States
Pa0008 205
Brno , , Czechia
Pa0008 207
Olomouc , , Czechia
Pa0008 210
Praha 11 , , Czechia
Pa0008 202
Praha 2 , , Czechia
Pa0008 201
Praha 4 , , Czechia
Pa0008 209
Praha 4 , , Czechia
Pa0008 203
Zlin , , Czechia
Pa0008 302
Cologne , , Germany
Pa0008 309
Erlangen , , Germany
Pa0008 304
Hamburg , , Germany
Pa0008 301
Ratingen , , Germany
Pa0008 403
Budakeszierdo , , Hungary
Pa0008 401
Veszprem , , Hungary
Pa0008 452
Bialystok , , Poland
Pa0008 453
Elblag , , Poland
Pa0008 456
Elblag , , Poland
Pa0008 455
Krakow , , Poland
Pa0008 451
Poznan , , Poland
Pa0008 450
Torun , , Poland
Pa0008 454
Warszawa , , Poland
Pa0008 459
Warszawa , , Poland
Pa0008 465
Wroclaw , , Poland
Pa0008 604
Moscow , , Russian Federation
Pa0008 605
Moscow , , Russian Federation
Pa0008 607
Moscow , , Russian Federation
Pa0008 606
Saint Petersburg , , Russian Federation
Pa0008 608
Saint Petersburg , , Russian Federation

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

206

Study ID:

NCT02969525

Recruitment Status:

Completed

Sponsor:


UCB Biopharma S.P.R.L.

How clear is this clinincal trial information?

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