Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03598790
Other study ID # PS0014
Secondary ID 2016-003427-30
Status Completed
Phase Phase 3
First received
Last updated
Start date September 5, 2018
Est. completion date November 14, 2023

Study information

Verified date December 2023
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).


Description:

The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.


Recruitment information / eligibility

Status Completed
Enrollment 1355
Est. completion date November 14, 2023
Est. primary completion date November 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Treatment Period (open-label) - Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator - Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria - Female subjects must be: 1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause 2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014 OLE2 Period (USA and Canada) - Completed the OLE Period without meeting any withdrawal criteria - Compliant with ongoing clinical study requirements - Female subject of childbearing potential must be willing to use highly effective method of contraception - Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only) - Signed a separate OLE2 Period ICF Exclusion Criteria: Treatment Period (open-label) - Subject has previously participated in this study - Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication - Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator - Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated - Subject may not participate in another study of a medicinal product or device under investigation other than the substudy - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen OLE2 Period (USA and Canada) - Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period - Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated - Presence of active suicidal ideation or severe depression - Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Locations

Country Name City State
Australia PS0014 7 Campbelltown
Australia PS0014 3 Carlton
Australia PS0014 8 East Melbourne
Australia PS0014 4 Fremantle
Australia Ps0014 10 Kogarah
Australia PS0014 6 Kogarah
Australia PS0014 5 Phillip
Australia PS0014 2 Westmead
Australia PS0014 9 Woolloongabba
Belgium Ps0014 50 Bruxelles
Belgium Ps0014 51 Charleroi
Belgium Ps0014 52 Liège
Canada Ps0014 658 Ajax
Canada Ps0014 659 Calgary
Canada Ps0014 672 Edmonton
Canada Ps0014 673 Halifax
Canada Ps0014 671 Hamilton
Canada Ps0014 675 Markham
Canada Ps0014 663 Mississauga
Canada Ps0014 660 Montreal
Canada Ps0014 668 North Bay
Canada Ps0014 652 Oakville
Canada Ps0014 667 Ottawa
Canada Ps0014 661 Peterborough
Canada Ps0014 665 Quebec City
Canada Ps0014 651 Richmond Hill
Canada Ps0014 650 Surrey
Canada Ps0014 676 Surrey
Canada Ps0014 653 Toronto
Canada Ps0014 662 Toronto
Canada Ps0014 664 Toronto
Canada Ps0014 657 Waterloo
Canada Ps0014 669 Windsor
Canada Ps0014 670 Windsor
Canada Ps0014 674 Winnipeg
Germany Ps0014 207 Berlin
Germany Ps0014 218 Bonn
Germany Ps0014 209 Darmstadt
Germany Ps0014 203 Dresden
Germany Ps0014 214 Erlangen
Germany Ps0014 208 Frankfurt
Germany Ps0014 210 Friedrichshafen
Germany Ps0014 202 Hamburg
Germany Ps0014 211 Hamburg
Germany Ps0014 220 Hamburg
Germany Ps0014 212 Heidelberg
Germany Ps0014 215 Lübeck
Germany Ps0014 213 Mahlow
Germany Ps0014 219 Münster
Germany Ps0014 205 Osnabrück
Germany Ps0014 217 Schweinfurt
Germany Ps0014 200 Schwerin
Germany Ps0014 204 Witten
Hungary Ps0014 252 Budapest
Hungary Ps0014 254 Budapest
Hungary Ps0014 255 Budapest
Hungary Ps0014 261 Budapest
Hungary Ps0014 256 Debrecen
Hungary Ps0014 262 Encs
Hungary Ps0014 251 Gyula
Hungary Ps0014 253 Orosháza
Hungary Ps0014 260 Szeged
Hungary Ps0014 259 Szekszárd
Hungary Ps0014 250 Szolnok
Hungary Ps0014 258 Veszprém
Italy Ps0014 300 Roma
Italy Ps0014 303 Roma
Japan Ps0014 629 Asahikawa
Japan Ps0014 605 Bunkyo-ku
Japan Ps0014 607 Chiyoda-ku
Japan Ps0014 610 Chuo-ku
Japan Ps0014 601 Fukuoka
Japan Ps0014 619 Gifu
Japan Ps0014 620 Hamamatsu
Japan Ps0014 608 Itabashi-ku
Japan Ps0014 609 Kobe
Japan Ps0014 600 Kurume
Japan Ps0014 622 Matsumoto
Japan Ps0014 604 Minato-ku
Japan Ps0014 623 Morioka
Japan Ps0014 621 Nagoya
Japan Ps0014 625 Nankoku
Japan Ps0014 624 Obihiro
Japan Ps0014 611 Osaka
Japan Ps0014 614 Osaka
Japan Ps0014 603 Sapporo
Japan Ps0014 617 Sendai
Japan Ps0014 613 Shimotsuke
Japan Ps0014 602 Shinagawa-ku
Japan Ps0014 612 Shinjuku-ku
Japan Ps0014 618 Shinjuku-ku
Japan Ps0014 626 Shinjuku-ku
Japan Ps0014 628 Shinjuku-ku
Japan Ps0014 606 Takaoka
Japan Ps0014 615 Tokyo
Japan Ps0014 627 Tokyo
Japan Ps0014 616 TSU
Korea, Republic of Ps0014 701 Busan
Korea, Republic of Ps0014 702 Gwangju
Korea, Republic of Ps0014 705 Seongnam-si
Korea, Republic of Ps0014 700 Seoul
Korea, Republic of Ps0014 703 Seoul
Poland Ps0014 355 Bialystok
Poland Ps0014 361 Bialystok
Poland Ps0014 362 Bialystok
Poland Ps0014 369 Bialystok
Poland Ps0014 371 Bydgoszcz
Poland Ps0014 352 Gdansk
Poland Ps0014 358 Katowice
Poland Ps0014 359 Katowice
Poland Ps0014 366 Katowice
Poland Ps0014 357 Kielce
Poland Ps0014 363 Krakow
Poland Ps0014 360 Lodz
Poland Ps0014 372 Lodz
Poland Ps0014 356 Lublin
Poland Ps0014 364 Nowa Sol
Poland Ps0014 374 Poznan
Poland Ps0014 353 Szczecin
Poland Ps0014 350 Warszawa
Poland Ps0014 351 Warszawa
Poland Ps0014 354 Warszawa
Poland Ps0014 365 Wroclaw
Poland Ps0014 367 Wroclaw
Poland Ps0014 368 Wroclaw
Poland Ps0014 370 Wroclaw
Poland Ps0014 373 Wroclaw
Russian Federation Ps0014 400 Moscow
Russian Federation Ps0014 402 Moscow
Russian Federation Ps0014 403 Moscow
Russian Federation Ps0014 405 Saint Petersburg
Russian Federation Ps0014 401 Saratov
Russian Federation Ps0014 404 St. Petersburg
Russian Federation Ps0014 406 Yaroslavl
Taiwan Ps0014 754 Taipei
Taiwan Ps0014 755 Taipei
United Kingdom Ps0014 551 Dundee
United Kingdom Ps0014 552 Liverpool
United Kingdom Ps0014 550 Manchester
United Kingdom Ps0014 554 Reading
United Kingdom Ps0014 555 Salford
United States Ps0014 941 Alpharetta Georgia
United States Ps0014 910 Bakersfield California
United States Ps0014 922 Baton Rouge Louisiana
United States Ps0014 940 Beverly Massachusetts
United States Ps0014 909 Boynton Beach Florida
United States Ps0014 925 Brighton Massachusetts
United States Ps0014 947 Buffalo New York
United States Ps0014 915 Clayton Missouri
United States Ps0014 912 Coral Gables Florida
United States Ps0014 931 Dallas Texas
United States Ps0014 908 East Windsor New Jersey
United States Ps0014 928 Fort Myers Florida
United States Ps0014 957 Glendale Arizona
United States Ps0014 945 Greer South Carolina
United States Ps0014 906 Hollywood Florida
United States Ps0014 924 Houston Texas
United States Ps0014 937 Johnston Rhode Island
United States Ps0014 965 Kew Gardens New York
United States Ps0014 927 Los Angeles California
United States Ps0014 907 Miami Florida
United States Ps0014 933 Murray Utah
United States Ps0014 944 New Orleans Louisiana
United States Ps0014 913 New York New York
United States Ps0014 903 Ocala Florida
United States Ps0014 932 Oklahoma City Oklahoma
United States Ps0014 958 Omaha Nebraska
United States Ps0014 921 Ormond Beach Florida
United States Ps0014 905 Overland Park Kansas
United States Ps0014 962 Owensboro Kentucky
United States Ps0014 946 Phoenix Arizona
United States Ps0014 911 Plainfield Indiana
United States Ps0014 920 Portland Oregon
United States Ps0014 929 Portland Oregon
United States Ps0014 901 Portsmouth New Hampshire
United States Ps0014 963 Rochester New York
United States Ps0014 961 Rocky Mount North Carolina
United States Ps0014 914 San Antonio Texas
United States Ps0014 919 San Diego California
United States Ps0014 955 San Diego California
United States Ps0014 943 San Luis Obispo California
United States Ps0014 967 Santa Monica California
United States Ps0014 954 Skokie Illinois
United States Ps0014 936 Tampa Florida
United States Ps0014 917 Troy Michigan
United States Ps0014 956 Verona New Jersey
United States Ps0014 934 Washington District of Columbia
United States Ps0014 951 Webster Texas
United States Ps0014 900 West Des Moines Iowa

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Taiwan,  United Kingdom, 

References & Publications (3)

Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Pooled data from up to three years of treatment in randomized — View 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 Tr — View Citation

Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the B — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used. From Baseline to Safety Follow Up 2 (up to Week 220)
Secondary Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used. From Baseline to Safety Follow Up 2 (up to Week 220)
Secondary Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used. From Baseline to Safety Follow Up 2 (up to Week 220)
Secondary Psoriasis Area Severity Index 90 (PASI90) response at Week 144 A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score. Week 144
Secondary Investigator´s Global Assessment (IGA) 0/1 response at Week 144 The Investigator will assess the overall severity of psoriasis using the following 5-point scale (five-point IGA):
0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present)
= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling)
= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling)
= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling)
= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions)
Week 144
See also
  Status Clinical Trial Phase
Completed NCT00799877 - Chronic Plaque Psoriasis (Ps) Registry
Completed NCT02581345 - Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis Phase 3
Withdrawn NCT01200264 - Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy Phase 2
Not yet recruiting NCT00707070 - Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis Phase 4
Terminated NCT00972543 - Raptiva in Palm and Sole Psoriasis Phase 4
Completed NCT00539929 - Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis Phase 2
Completed NCT02852967 - A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Phase 2
Completed NCT00770965 - Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis Phase 2
Active, not recruiting NCT06011733 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT00245765 - Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy Phase 2
Completed NCT00673556 - A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate Phase 3
Terminated NCT00844363 - Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris N/A
Completed NCT00574249 - Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment Phase 3
Completed NCT00512187 - Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial Phase 4
Completed NCT02570750 - The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Completed NCT00438360 - Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis Phase 3
Active, not recruiting NCT03897075 - Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis Phase 3
Completed NCT01358578 - Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis Phase 3
Completed NCT03536884 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Completed NCT03230292 - A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis Phase 2