Phase 2 Completed N=49 Randomized Double-blind Treatment

A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

Source: ClinicalTrials.gov NCT03025542 ↗

Enrolled (actual)

Serious AEs

6.1%

Results posted

Jan 2021

Primary outcomePrimary: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 — -10.76; -19.74 scores on a scale

Summary

This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28	-10.76; -19.74	—
PRIMARY Plasma Concentration of Bimekizumab at Baseline	NA; NA	—
PRIMARY Plasma Concentration of Bimekizumab at Week 2	19.749; 14.437	—
PRIMARY Plasma Concentration of Bimekizumab at Week 4	11.402; 9.077	—
PRIMARY Plasma Concentration of Bimekizumab at Week 8	16.728; 13.969	—
PRIMARY Plasma Concentration of Bimekizumab at Week 12	5.972; 5.466	—
PRIMARY Plasma Concentration of Bimekizumab at Week 16	2.200; 2.293	—
PRIMARY Plasma Concentration of Bimekizumab at Week 20	0.798; 9.702	—
PRIMARY Plasma Concentration of Bimekizumab at Week 24	NA; 4.377	—
PRIMARY Plasma Concentration of Bimekizumab at Week 28	NA; 1.933	—
PRIMARY Plasma Concentration of Bimekizumab at Week 36	NA; 0.322	—
PRIMARY Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline	3.1; 0	—
PRIMARY Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab	34.4; 47.1	—
PRIMARY Percentage of Participants Who Experienced at Least One Adverse Events (AEs)	87.5; 88.2	—
SECONDARY Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16	93.8; 88.2	—
SECONDARY Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16	84.4; 70.6	—
SECONDARY Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16	46.9; 52.9	—
SECONDARY Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16	81.3; 64.7	—

Eligibility Criteria

Inclusion Criteria

Male or female at least 18 years of age and less than or equal to 70
Chronic plaque psoriasis for at least 6 months prior to Screening
Psoriasis Area and Severity Index (PASI) >=12 and body surface area (BSA) >=10% and Investigator's Global Assessment (IGA) score >=3 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, 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 a bimekizumab study
Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster)
High risk of infection in the Investigator's opinion
Current sign or symptom that may indicate an active infection
Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignant condition as defined in the protocol)
Primary immunosuppressive conditions
TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection
Laboratory abnormalities, as defined in the study protocol
Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study
Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit
Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis
Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline
Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03025542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.