Clinical trial NCT02905006: Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: Psoriasis
Chronic Plaque Psoriasis
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2016-09-19
Enrollment: 250
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 Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.


Eligibility criteria: Inclusion Criteria:

* Subject has provided informed consent
* Chronic plaque psoriasis for at least 6 months prior to Screening
* PASI (Psoriasis Area and Severity Index) \>=12 and BSA (body surface area) \>=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
* Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication

Exclusion Criteria:

* Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
* Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
* Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject taking prohibited psoriatic medications
* Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
* Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
* Subject has any current sign or symptom that may indicate an active infection (except for common cold)

Primary outcomes:
measure: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
timeFrame: Week 12
measure: Plasma Concentrations of Bimekizumab During the Study
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
timeFrame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
measure: Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
timeFrame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
measure: Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
timeFrame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
measure: Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
timeFrame: From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
measure: Percentage of Participants With at Least One Adverse Event (AE) During the Study
timeFrame: From Screening to End of Safety Follow-up (up to Week 32)
measure: Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity
timeFrame: From Screening to End of Safety Follow-up (up to Week 32)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)
timeFrame: From Baseline (Week 0) until Week 12
measure: Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)
timeFrame: From Baseline (Week 0) until Week 12
measure: Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)
timeFrame: From Baseline (Week 0) until Week 12
measure: Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)
timeFrame: From Baseline (Week 0) until Week 12
measure: Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)
timeFrame: From Baseline (Week 0) until Week 12
measure: Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature)
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
measure: Percentage of Participants With Clinically Significant Physical Examination Abnormalities
timeFrame: At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)
measure: Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Ps0010 711
state: California
city: Los Angeles
country: United States
facility: Ps0010 708
state: California
city: Washington
country: United States
facility: Ps0010 706
state: District of Columbia
city: West Des Moines
country: United States
facility: Ps0010 704
state: Iowa
city: Rochester
country: United States
facility: Ps0010 718
state: New York
city: Wilmington
country: United States
facility: Ps0010 738
state: North Carolina
city: Cleveland
country: United States
facility: Ps0010 736
state: Ohio
city: Portland
country: United States
facility: Ps0010 712
state: Oregon
city: Dallas
country: United States
facility: Ps0010 733
state: Texas
city: Houston
country: United States
facility: Ps0010 702
state: Texas
city: Houston
country: United States
facility: Ps0010 709
state: Texas
city: Surrey
country: Canada
facility: Ps0010 203
state: British Columbia
city: Hamilton
country: Canada
facility: Ps0010 204
state: Ontario
city: North Bay
country: Canada
facility: Ps0010 201
state: Ontario
city: Peterborough
country: Canada
facility: Ps0010 206
state: Ontario
city: Waterloo
country: Canada
facility: Ps0010 205
state: Ontario
city: Quebec City
country: Canada
facility: Ps0010 214
state: Quebec
city: Edmonton
country: Canada
facility: Ps0010 209
city: Quebec City
country: Canada
facility: Ps0010 214
city: Ostrava Poruba
country: Czechia
facility: Ps0010 300
city: Pardubice
country: Czechia
facility: Ps0010 303
city: Praha
country: Czechia
facility: Ps0010 301
city: Praha
country: Czechia
facility: Ps0010 304
city: Kecskemet
country: Hungary
facility: Ps0010 404
city: Oroshaza
country: Hungary
facility: Ps0010 400
city: Szekszard
country: Hungary
facility: Ps0010 405
city: Nagoya
country: Japan
facility: Ps0010 502
city: Shinaga Wa-ku
country: Japan
facility: Ps0010 501
city: Tokio
country: Japan
facility: Ps0010 503
city: Tokyo
country: Japan
facility: Ps0010 504
city: Bialystok
country: Poland
facility: Ps0010 600
city: Bialystok
country: Poland
facility: Ps0010 611
city: Gdansk
country: Poland
facility: Ps0010 605
city: Gdynia
country: Poland
facility: Ps0010 610
city: Kielce
country: Poland
facility: Ps0010 604
city: Krakow
country: Poland
facility: Ps0010 608
city: Lublin
country: Poland
facility: Ps0010 606
city: Podlaski
country: Poland
facility: Ps0010 603
city: Warszawa
country: Poland
facility: Ps0010 607
city: Wroclaw
country: Poland
facility: Ps0010 601
city: Wroclaw
country: Poland
facility: Ps0010 609
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.