Study to test the efficacy and safety of bimekizumab andcertolizumab pegol in patients with active ankylosing spondylitis
- Conditions
- Ankylosing SpondylitisMedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-000957-37-DE
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
- 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 <45 years
- Subject has moderate to severe active disease at the Screening Visit as defined by each of the following:
a) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >=4
b) 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 <=10mg/day oral prednisolone or
equivalent
- Subjects taking methotrexate (MTX; <=25mg/week) are allowed to continue their medication if they
received a stable dose for at least 12 weeks before randomization
- Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are
allowed to continue their medication if started at least 12 weeks prior to randomization
- Subject who has been on an anti-TNF agent must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months or have been intolerant to at least 1 administration of an anti-tumor necrosis factor alpha (TNF) agent. Subjects may not have been on more than 1 anti-TNF agent.
- Subject has high-sensitive C-Reactive Protein (hsCRP) levels above ULN 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- 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 TNF 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 immunodeficinecy 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:
a. <= 3 excised or ablated basal cell carcinomas of the skin
b. 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
c. Actinic keratosis (-es)
d. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the efficacy of bimekizumab compared to certolizumab pegol (CZP) in the treatment of subjects with active Ankylosing Spondylitis (AS);Secondary Objective: Assess the safety and the tolerability of bimekizumab;Primary end point(s): 1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12<br>2. Incidence of Adverse Events (AE) during the study conduct<br>3. Incidence of Serious Adverse Events (SAEs) during the study conduct<br>4. Number of subjects who withdrew due to an Adverse Event (AE) during the study conduct<br>;Timepoint(s) of evaluation of this end point: 1: From Baseline to Week 12<br>2-4: From Screening until Safety Follow-Up Visit (up to Week 64)<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Percentage of subjects with Ankylosing Spondylitis Disease Activity Score -Inactive Disease (ASDAS-ID) at Week 12<br>2. Percentage of subjects with Ankylosing Spondylitis Disease Activity Score - Major Improvement (ASDAS-MI) at Week 12<br>;Timepoint(s) of evaluation of this end point: 1: Week 12<br>2: Baseline, Week 12