Clinical trial NCT02969525: 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
Official title: A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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:

  1. experienced an inadequate response to previous treatment given for at least 3 months
  2. been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
  3. 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:

  1. \<= 3 excised or ablated basal cell carcinomas of the skin
  2. 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
  3. Actinic keratosis (-es)
  4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

Primary outcomes:
measure: ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12
timeFrame: Week 12
measure: ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12
timeFrame: Week 12
measure: PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
timeFrame: Week 12
measure: PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1
timeFrame: Week 12
measure: Percentage of Participants With at Least One Adverse Event (AE) During the Study
timeFrame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
timeFrame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
measure: Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
timeFrame: From Screening Period until the Safety Follow-Up Visit (up to Week 72)
measure: Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)
timeFrame: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
measure: Changes From Baseline in Vital Signs During the Study (Pulse Rate)
timeFrame: Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48
measure: Changes From Baseline in Body Weight During the Study
timeFrame: Baseline, Week 12, Week 24, Week 36 and Week 48
measure: Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)
timeFrame: Baseline, Week 12 and Week 48
measure: Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Hematology Parameters During the Study (Hematocrit)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Hematology Parameters During the Study (Platelets)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Biochemistry Parameters During the Study (Albumin)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
measure: Changes From Baseline in Urinalysis Parameters During the Study (pH)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pa0008 007
state: California
city: Aventura
country: United States
facility: Pa0008 005
state: Florida
city: Hagerstown
country: United States
facility: Pa0008 003
state: Maryland
city: Lansing
country: United States
facility: Pa0008 011
state: Minnesota
city: Lexington
country: United States
facility: Pa0008 025
state: New York
city: Portland
country: United States
facility: Pa0008 014
state: Oregon
city: Duncansville
country: United States
facility: Pa0008 001
state: Pennsylvania
city: Johnston
country: United States
facility: Pa0008 012
state: Rhode Island
city: Charleston
country: United States
facility: Pa0008 004
state: South Carolina
city: Jackson
country: United States
facility: Pa0008 010
state: Tennessee
city: Dallas
country: United States
facility: Pa0008 006
state: Texas
city: Mesquite
country: United States
facility: Pa0008 013
state: Texas
city: Seattle
country: United States
facility: Pa0008 002
state: Washington
city: Brno
country: Czechia
facility: Pa0008 205
city: Olomouc
country: Czechia
facility: Pa0008 207
city: Praha 11
country: Czechia
facility: Pa0008 210
city: Praha 2
country: Czechia
facility: Pa0008 202
city: Praha 4
country: Czechia
facility: Pa0008 201
city: Praha 4
country: Czechia
facility: Pa0008 209
city: Zlin
country: Czechia
facility: Pa0008 203
city: Cologne
country: Germany
facility: Pa0008 302
city: Erlangen
country: Germany
facility: Pa0008 309
city: Hamburg
country: Germany
facility: Pa0008 304
city: Ratingen
country: Germany
facility: Pa0008 301
city: Budakeszierdo
country: Hungary
facility: Pa0008 403
city: Veszprem
country: Hungary
facility: Pa0008 401
city: Bialystok
country: Poland
facility: Pa0008 452
city: Elblag
country: Poland
facility: Pa0008 453
city: Elblag
country: Poland
facility: Pa0008 456
city: Krakow
country: Poland
facility: Pa0008 455
city: Poznan
country: Poland
facility: Pa0008 451
city: Torun
country: Poland
facility: Pa0008 450
city: Warszawa
country: Poland
facility: Pa0008 454
city: Warszawa
country: Poland
facility: Pa0008 459
city: Wroclaw
country: Poland
facility: Pa0008 465
city: Moscow
country: Russian Federation
facility: Pa0008 604
city: Moscow
country: Russian Federation
facility: Pa0008 605
city: Moscow
country: Russian Federation
facility: Pa0008 607
city: Saint Petersburg
country: Russian Federation
facility: Pa0008 606
city: Saint Petersburg
country: Russian Federation
facility: Pa0008 608
Study officials:
affiliation: +1 844 599 2273(UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Mease PJ, Asahina A, Gladman DD, Tanaka Y, Tillett W, Ink B, Assudani D, de la Loge C, Coarse J, Eells J, Gossec L. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford). 2023 Feb 1;62(2):617-628. doi: 10.1093/rheumatology/keac353.
citation: Ritchlin CT, Kavanaugh A, Merola JF, Schett G, Scher JU, Warren RB, Gottlieb AB, Assudani D, Bedford-Rice K, Coarse J, Ink B, McInnes IB. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2020 Feb 8;395(10222):427-440. doi: 10.1016/S0140-6736(19)33161-7.