A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Psoriatic Arthritis Clinical Trial

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Official title:

A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410992
• Other study ID #: PS0013
• Secondary ID: 2016-003426-16
• Status: Completed
• Phase: Phase 3
• Start date: February 5, 2018
• Est. completion date: January 7, 2020

Study information

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

Clinical Trial Summary

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: January 7, 2020
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be at least 18 years of age

• Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

• Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

• Subject is a candidate for systemic PSO therapy and/or phototherapy

• Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

• Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections

• Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection

• Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

• Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study

• Presence of active suicidal ideation or positive suicide behavior

• Presence of moderately severe major depression or severe major depression

• Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Chronic Plaque Psoriasis
• Moderate to Severe Chronic Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis

Intervention

Drug:
• Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.

Other:
• Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Locations

Country	Name	City	State
Australia	Ps0013 003	Carlton
Australia	Ps0013 008	East Melbourne
Australia	Ps0013 006	Kogarah
Canada	Ps0013 658	Ajax
Canada	Ps0013 672	Edmonton
Canada	Ps0013 671	Hamilton
Canada	Ps0013 675	Markham
Canada	Ps0013 663	Mississauga
Canada	Ps0013 660	Montréal
Canada	Ps0013 668	North Bay
Canada	Ps0013 667	Ottawa
Canada	Ps0013 665	Québec
Canada	Ps0013 676	Surrey
Canada	Ps0013 657	Waterloo
Germany	Ps0013 202	Hamburg
Germany	Ps0013 220	Hamburg
Germany	Ps0013 219	Münster
Germany	Ps0013 200	Schwerin
Germany	Ps0013 204	Witten
Hungary	Ps0013 261	Budapest
Hungary	Ps0013 262	Miskolc
Hungary	Ps0013 253	Orosháza
Hungary	Ps0013 260	Szeged
Hungary	Ps0013 250	Szolnok
Hungary	Ps0013 258	Veszprém
Korea, Republic of	Ps0013 701	Busan
Korea, Republic of	Ps0013 705	Seongnam-si
Korea, Republic of	Ps0013 703	Seoul
Poland	Ps0013 355	Bialystok
Poland	Ps0013 361	Bialystok
Poland	Ps0013 369	Bialystok
Poland	Ps0013 352	Gdansk
Poland	Ps0013 358	Katowice
Poland	Ps0013 359	Katowice
Poland	Ps0013 366	Katowice
Poland	Ps0013 357	Kielce
Poland	Ps0013 363	Kraków
Poland	Ps0013 360	Lódz
Poland	Ps0013 356	Lublin
Poland	Ps0013 374	Poznan
Poland	Ps0013 353	Szczecin
Poland	Ps0013 350	Warsaw
Poland	Ps0013 351	Warsaw
Poland	Ps0013 354	Warszawa
Poland	Ps0013 365	Wroclaw
Poland	Ps0013 368	Wroclaw
Poland	Ps0013 370	Wroclaw
Russian Federation	Ps0013 400	Moscow
Russian Federation	Ps0013 402	Moscow
Russian Federation	Ps0013 403	Moscow
Russian Federation	Ps0013 404	Saint Petersburg
Russian Federation	Ps0013 405	Saint Petersburg
Russian Federation	Ps0013 401	Saratov
Russian Federation	Ps0013 406	Yaroslavl
United Kingdom	Ps0013 550	Manchester
United Kingdom	Ps0013 554	Reading
United Kingdom	Ps0013 555	Salford
United States	Ps0013 940	Beverly	Massachusetts
United States	Ps0013 947	Buffalo	New York
United States	Ps0013 949	Cleveland	Ohio
United States	Ps0013 928	Fort Myers	Florida
United States	Ps0013 937	Johnston	Rhode Island
United States	Ps0013 933	Murray	Utah
United States	Ps0013 944	New Orleans	Louisiana
United States	Ps0013 965	New York	New York
United States	Ps0013 968	New York	New York
United States	Ps0013 962	Owensboro	Kentucky
United States	Ps0013 929	Portland	Oregon
United States	Ps0013 901	Portsmouth	New Hampshire
United States	Ps0013 963	Rochester	New York
United States	Ps0013 914	San Antonio	Texas
United States	Ps0013 919	San Diego	California
United States	Ps0013 955	San Diego	California
United States	Ps0013 966	Sandy Springs	Georgia
United States	Ps0013 967	Santa Monica	California
United States	Ps0013 954	Skokie	Illinois
United States	Ps0013 956	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Hungary,  Korea, Republic of,  Poland,  Russian Federation,  United Kingdom, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16
Primary	Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-Inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16
Secondary	Percentage of Participants With a PASI100 Response at Week 16	A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16
Secondary	Percentage of Participants With a IGA Clear Response at Week 16	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear with at least >= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16
Secondary	Percentage of Participants With a PASI75 Response at Week 4	A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders.	At Week 4
Secondary	Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16	As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.; PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.	At Week 16
Secondary	Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16	A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.; PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.	At Week 16
Secondary	Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16	As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.	At Week 16
Secondary	Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline	Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.	At Week 16
Secondary	Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders	A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).	At Week 56
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.	From Baseline to end of Initial Treatment Period (up to Week 16)
Secondary	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Baseline to end of Initial Treatment Period (up to Week 16)
Secondary	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Baseline to end of Initial Treatment Period (up to Week 16)
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Secondary	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Secondary	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Secondary	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Secondary	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Secondary	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

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