Phase 2 N=76 Randomized Quadruple-blind Treatment

A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT03215277 ↗

Enrolled (actual)

Serious AEs

10.5%

Results posted

Jul 2023

Primary outcome: Primary: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 — -1.83; -2.06 scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bimekizumab (Drug); Certolizumab pegol (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB Biopharma SRL
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12	-1.83; -2.06	—
PRIMARY Number of Participants With Adverse Events (AE) During the Study Conduct	19; 42	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct	3; 5	—
PRIMARY Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct	3; 3	—
SECONDARY Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12	5; 11	—
SECONDARY Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12	11; 28	—

Summary

The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared to certolizumab pegol in the treatment of subjects with active ankylosing spondylitis (AS).

Eligibility Criteria

Inclusion Criteria

Documented diagnosis of active adult-onset ankylosing spondylitis (AS) as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset =4
Spinal pain >=4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)
Subjects must have had an inadequate response to, have a contraindication to, or have been intolerant to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs)
Subjects taking corticosteroids must be on a maximum daily dose of =3 mg/L at the Screening Visit
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 investigational medicinal product (IMP)
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 IMP

Exclusion Criteria

Subject has received previous or current biological treatment other than TNFα inhibitor treatment
Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg, rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
Subject has received previous or current biological treatment other than TNFα inhibitor treatment
Subject has chronic, recurrent, recent serious / life-threatening or current infection, as defined in the protocol
Subject has history of certain atypical infections, viral hepatitides, human immunodeficiency virus (HIV) infection, tuberculosis, as defined in the protocol
Subjects receiving any live vaccination within the 8 weeks prior to Baseline
Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
Subject has immunosuppressive condition or treatment, recent history of malignancy (some exceptions) or demyelinating disease
Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
<= 3 excised or ablated basal cell carcinomas of the skin
One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
Actinic keratosis (-es)
Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
Subject has history of psychiatric disorder, including suicidality (as defined in the protocol
Subject has major abnormalities on laboratory testing, as defined in the protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03215277). 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.