A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.

Phase 1

• Conditions: Ankylosing Spondylitis; MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001102-42-HU
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-28
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

- Subject has active AS, determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for >=3 months and age of onset <45 years
- Subject has moderate to severe active disease as defined by each of the following:
--BASDAI score >=4
--Spinal pain >=4 on a 0 to 10 NRS (from BASDAI item 2)
- Subjects must have at least 1 of the following:
-- inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
-- intolerance to administration of at least 1 NSAID
-- contraindication(s) to NSAID therapy
- Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
- Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
- Subjects taking MTX (<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 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 Baseline, with a stable dose for at least 8 weeks before randomization
- Subjects may be TNF inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
--experienced an inadequate response to previous treatment given for at least 3 months
-- been intolerant to administration (eg, had a side effect/AE that led to discontinuation)
-- lost access to TNF inhibitor for other reasons
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg,rheumatoid arhritis (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)
- Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
- Subjects receiving any live vaccination within the 8 weeks prior to Baseline
- Subjects with known tubercolosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
- Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be indlucded:
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified