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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03215277
Date of registration: 05/07/2017
Prospective Registration: Yes
Primary sponsor: UCB Biopharma S.P.R.L.
Public title: A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis
Scientific title: A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing Spondylitis
Date of first enrolment: October 4, 2017
Target sample size: 76
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03215277
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Australia Czechia Germany Greece Moldova, Republic of Netherlands Poland Russian Federation
United States
Contacts
Name:     UCB Cares
Address: 
Telephone:
Email:
Affiliation:  +1-844-599-2273 (UCB)
Key inclusion & exclusion 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 (TNFa) 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-TNFa agent. Subjects may not have been on more than 1
anti-TNFa 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 TNFa
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 TNFa
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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Drug: Bimekizumab
Drug: Certolizumab pegol
Other: Placebo
Primary Outcome(s)
Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 [Time Frame: From Baseline to Week 12]
Incidence of adverse events (AE) during the study conduct [Time Frame: From Screening until Safety Follow-Up Visit (up to Week 64)]
Incidence of serious adverse events (SAEs) during the study conduct [Time Frame: From Screening until Safety Follow-Up Visit (up to Week 64)]
Number of subjects who withdrew due to an adverse event (AE) during the study conduct [Time Frame: From Screening until Safety Follow-Up Visit (up to Week 64)]
Secondary Outcome(s)
Percentage of subjects with Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12 [Time Frame: Week 12]
Percentage of subjects with Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12 [Time Frame: Baseline, Week 12]
Secondary ID(s)
2017-000957-37
AS0013
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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