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

NCT03215277 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: AS00132017-000957-37
• Study Type: interventional
• Target: 76
• Locations: 8 countries
• Sites: 34

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

Keywords

Ankylosing Spondylitis; Bimekizumab; AS; Certolizumab Pegol; Cimzia

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

  ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP \[mg/L\] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Posterior means and 95% credible intervals in each group are presented.

  From Baseline to Week 12

• Number of Participants With Adverse Events (AE) During the Study Conduct

  An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

  From Baseline until Safety Follow-Up Visit (up to Week 64)

• Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct

  An SAE was any untoward medical occurrence that at any dose: - Resulted in death - Is life-threatening - Required in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment with parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardised the participants, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

  From Baseline until Safety Follow-Up Visit (up to Week 64)

• Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct

  An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

  From Baseline until Safety Follow-Up Visit (up to Week 64)

Secondary Outcomes (2)

• Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12

  Week 12

• Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12

  Baseline, Week 12

Study Arms (2)

Bimekizumab

EXPERIMENTAL

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.

Drug: Bimekizumab; Other: Placebo

Certolizumab pegol

EXPERIMENTAL

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

Drug: Certolizumab pegol

Interventions

Bimekizumab DRUG

One bimekizumab dose will be administered.

Also known as: UCB4940, BKZ

Bimekizumab

Certolizumab pegol DRUG

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

Also known as: CZP, Cimzia, CDP870

Certolizumab pegol

Placebo OTHER

Placebo will be provided to maintain the blinding.

Bimekizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>=4
• 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

You may not qualify if:

• 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:
• \<= 3 excised or ablated basal cell carcinomas of the skin
• 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
• Actinic keratosis (-es)
• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (34)

As0013 908

Ormond Beach, Florida, 32174, United States

Location

As0013 903

Lincoln, Nebraska, 68516, United States

Location

As0013 902

Oklahoma City, Oklahoma, 73103, United States

Location

As0013 906

Memphis, Tennessee, 38119, United States

Location

As0013 202

Kladno, Czechia

Location

As0013 205

Ostrava, Czechia

Location

As0013 201

Prague, Czechia

Location

As0013 203

Prague, Czechia

Location

As0013 302

Berlin, Germany

Location

As0013 306

Berlin, Germany

Location

As0013 304

Erlangen, Germany

Location

As0013 303

Hamburg, Germany

Location

As0013 301

Herne, Germany

Location

As0013 405

Athens, Greece

Location

As0013 404

Heraklion, Greece

Location

As0013 401

Pátrai, Greece

Location

As0013 402

Thessaloniki, Greece

Location

As0013 406

Thessaloniki, Greece

Location

As0013 501

Chisinau, Moldova

Location

As0013 601

Amsterdam, Netherlands

Location

As0013 708

Bialystok, Poland

Location

As0013 709

Krakow, Poland

Location

As0013 706

Olsztyn, Poland

Location

As0013 703

Poznan, Poland

Location

As0013 702

Torun, Poland

Location

As0013 701

Warsaw, Poland

Location

As0013 704

Warsaw, Poland

Location

As0013 707

Wroclaw, Poland

Location

As0013 801

Kazan', Russia

Location

As0013 803

Kemerovo, Russia

Location

As0013 806

Moscow, Russia

Location

As0013 807

Moscow, Russia

Location

As0013 802

Yaroslavl, Russia

Location

As0013 805

Yaroslavl, Russia

Location

Related Publications (1)

• 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.

  PMID: 39620046 DERIVED

Related Links

• Product Information
• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

bimekizumab; Certolizumab Pegol

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  +1-844-599-2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an investigator-blind and subject-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 12, 2017
• Study Start: October 4, 2017
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

RU (6); DE (5); GR (5); CZ (4); US (4); MO (1); PL (8); NL (1)