Clinical trial NCT03230292: A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
Official title: A Multicenter, 48-week, Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy 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
First posted: 2017-07-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.


Eligibility criteria: Inclusion Criteria:

* Subject must have completed all dosing requirements in PS0016 without meeting any withdrawal criteria
* 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, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
* 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 (anticipated 5 half-lives)

Exclusion Criteria:

* Subjects previously participating in this study
* 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 (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subject's entry into PS0018
* Subject has any current sign or symptom that may indicate a medically significant infection
* Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed.
* Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018)

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment
timeFrame: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)
Secondary outcomes:
measure: Plasma Concentration of Bimekizumab During the Study
timeFrame: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)
measure: Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment
timeFrame: Baseline of study PS0016 [NCT03025542]
measure: Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study
timeFrame: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
measure: Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study
timeFrame: Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]
measure: Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study
timeFrame: Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]
measure: Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study
timeFrame: Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018
measure: Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study
timeFrame: Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018
Other outcomes:
Locations:
city: High Point
country: United States
facility: Ps0018 701
state: North Carolina
city: Bexley
country: United States
facility: Ps0018 704
state: Ohio
city: Carlton
country: Australia
facility: Ps0018 101
city: East Melbourne
country: Australia
facility: Ps0018 103
city: Kogarah
country: Australia
facility: Ps0018 102
city: Woolloongabba
country: Australia
facility: Ps0018 104
city: Ajax
country: Canada
facility: Ps0018 201
city: London
country: Canada
facility: Ps0018 203
city: Windsor
country: Canada
facility: Ps0018 202
city: Chisinau
country: Moldova, Republic of
facility: Ps0018 501
Study officials:
affiliation: UCB (001 844 599 2273)
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.