A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

NCT ID: NCT03215277

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2020-05-25

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).

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bimekizumab

Intervention Type: DRUG

One bimekizumab dose will be administered.

Placebo

Intervention Type: OTHER

Placebo will be provided to maintain the blinding.

Certolizumab pegol

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

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: DRUG

Two certolizumab pegol doses will be administered. One of these doses is a loading dose.

Interventions

Bimekizumab

One bimekizumab dose will be administered.

Intervention Type: DRUG

Certolizumab pegol

Two certolizumab pegol doses will be administered. One of these doses is a loading dose.

Intervention Type: DRUG

Placebo

Placebo will be provided to maintain the blinding.

Intervention Type: OTHER

Other Intervention Names

UCB4940; BKZ; CZP; Cimzia; CDP870

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

+1-844-599-2273 (UCB)

Locations

As0013 908

Ormond Beach, Florida, United States

As0013 903

Lincoln, Nebraska, United States

As0013 902

Oklahoma City, Oklahoma, United States

As0013 906

Memphis, Tennessee, United States

As0013 202

Kladno, , Czechia

As0013 205

Ostrava, , Czechia

As0013 201

Prague, , Czechia

As0013 203

Prague, , Czechia

As0013 302

Berlin, , Germany

As0013 306

Berlin, , Germany

As0013 304

Erlangen, , Germany

As0013 303

Hamburg, , Germany

As0013 301

Herne, , Germany

As0013 405

Athens, , Greece

As0013 404

Heraklion, , Greece

As0013 401

Pátrai, , Greece

As0013 402

Thessaloniki, , Greece

As0013 406

Thessaloniki, , Greece

As0013 501

Chisinau, , Moldova

As0013 601

Amsterdam, , Netherlands

As0013 708

Bialystok, , Poland

As0013 709

Krakow, , Poland

As0013 706

Olsztyn, , Poland

As0013 703

Poznan, , Poland

As0013 702

Torun, , Poland

As0013 701

Warsaw, , Poland

As0013 704

Warsaw, , Poland

As0013 707

Wroclaw, , Poland

As0013 801

Kazan', , Russia

As0013 803

Kemerovo, , Russia

As0013 806

Moscow, , Russia

As0013 807

Moscow, , Russia

As0013 802

Yaroslavl, , Russia

As0013 805

Yaroslavl, , Russia

Countries

United States; Czechia; Germany; Greece; Moldova; Netherlands; Poland; Russia

References

Baraliakos X, de Jongh J, Poddubnyy D, Zwezerijnen GJC, Hemke R, Glatt S, Shaw S, Ionescu L, El Baghdady A, Mann J, Maguire RP, Vaux T, de Peyrecave N, Oortgiesen M, Baeten D, van der Laken C. Impact of bimekizumab and certolizumab pegol on efficacy, safety and osteoblastic activity in radiographic axial spondyloarthritis: results from a phase IIa, multicentre, randomised, double-blind, exploratory study with PET-CT imaging. Ther Adv Musculoskelet Dis. 2024 Nov 28;16:1759720X241293944. doi: 10.1177/1759720X241293944. eCollection 2024.

Reference Type: DERIVED

PMID: 39620046 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.ucb.com/_up/ucb_com_products/documents/Cimzia_01_03_2023_en.pdf

Product Information

https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

Product Information

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2017-000957-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AS0013

Identifier Type: -

Identifier Source: org_study_id