A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Bimekizumab; Certolizumab pegol; Placebo
Intervention description: One bimekizumab dose will be administered.; Two certolizumab pegol doses will be administered. One of these doses is a loading dose.; Placebo will be provided to maintain the blinding.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This is an investigator-blind and subject-blind study.
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis; Bimekizumab; AS; Certolizumab Pegol; Cimzia

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 <45 years

          -  Subject has moderate to severe active disease at the Screening Visit as defined by
             each of the following:

               1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >=4

               2. 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; <=25 mg/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 3 grams/day) or hydroxychloroquine (up to 400 mg
             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-tumor necrosis factor alpha (TNFα) 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-TNFα agent. Subjects may not have been on more than 1
             anti-TNFα agent

          -  Subject has high-sensitive C-Reactive Protein (hsCRP) levels >=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:

               1. <= 3 excised or ablated basal cell carcinomas of the skin

               2. 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

               3. Actinic keratosis (-es)

               4. 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