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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03215277




Registration number
NCT03215277
Ethics application status
Date submitted
5/07/2017
Date registered
12/07/2017
Date last updated
27/07/2023

Titles & IDs
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
Secondary ID [1] 0 0
2017-000957-37
Secondary ID [2] 0 0
AS0013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Certolizumab pegol
Other interventions - Placebo

Experimental: Bimekizumab - Subjects will receive several bimekizumab administrations on pre-defined time points. Placebo will be provided in this arm to mask the certolizumab pegol loading dose.

Experimental: Certolizumab pegol - Subjects will receive several certolizumab pegol administrations on pre-defined time points.


Treatment: Drugs: Bimekizumab
One bimekizumab dose will be administered.

Treatment: Drugs: Certolizumab pegol
Two certolizumab pegol doses will be administered. One of these doses is a loading dose.

Other interventions: Placebo
Placebo will be provided to maintain the blinding.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
Timepoint [1] 0 0
From Baseline to Week 12
Primary outcome [2] 0 0
Number of Participants With Adverse Events (AE) During the Study Conduct
Timepoint [2] 0 0
From Baseline until Safety Follow-Up Visit (up to Week 64)
Primary outcome [3] 0 0
Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct
Timepoint [3] 0 0
From Baseline until Safety Follow-Up Visit (up to Week 64)
Primary outcome [4] 0 0
Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct
Timepoint [4] 0 0
From Baseline until Safety Follow-Up Visit (up to Week 64)
Secondary outcome [1] 0 0
Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12
Timepoint [2] 0 0
Baseline, Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2020
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Czechia
State/province [5] 0 0
Kladno
Country [6] 0 0
Czechia
State/province [6] 0 0
Ostrava
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 2
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha 3
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Erlangen
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Herne
Country [13] 0 0
Greece
State/province [13] 0 0
Athens
Country [14] 0 0
Greece
State/province [14] 0 0
Heraklion
Country [15] 0 0
Greece
State/province [15] 0 0
Patra
Country [16] 0 0
Greece
State/province [16] 0 0
Thessaloníki
Country [17] 0 0
Moldova, Republic of
State/province [17] 0 0
Chisinau
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Poland
State/province [19] 0 0
Bialystok
Country [20] 0 0
Poland
State/province [20] 0 0
Kraków
Country [21] 0 0
Poland
State/province [21] 0 0
Olsztyn
Country [22] 0 0
Poland
State/province [22] 0 0
Poznan
Country [23] 0 0
Poland
State/province [23] 0 0
Torun
Country [24] 0 0
Poland
State/province [24] 0 0
Warsaw
Country [25] 0 0
Poland
State/province [25] 0 0
Warszawa
Country [26] 0 0
Poland
State/province [26] 0 0
Wroclaw
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Kazan
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Kemerovo
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Yaroslavl

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT03215277
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1-844-599-2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03215277