Clinical trial NCT02430909: Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis
Official title: A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2015-04-30
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.


Eligibility criteria: Inclusion Criteria

To be eligible to participate in this study, all of the following criteria must be met:

* Subject is informed and given approved written Informed Consent Form (ICF).
* Subject is considered reliable and capable of adhering to the protocol.
* Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months' duration as defined by ACR/EULAR 2010 classification criteria.
* Subject must have:

  * ≥6 tender joints (out of 68)
  * ≥6 swollen joints (out of 66)
  * CRP≥10.0mg/L .
* Subject must have had inadequate response to at least 1 synthetic DMARD.
* Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening).
* Female subjects must either be:

  * postmenopausal
  * permanently sterilized or,
  * if of childbearing potential, must be willing to use at least 2 effective methods of contraception,
* Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug.

Exclusion Criteria

Subjects are not permitted to enroll in the study if any of the following criteria is met:

* Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP).
* Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens.
* Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded.
* Subject is at high risk of infection.
* Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0.
* Subject has renal or liver impairment.
* Subject has a current or past history of gastrointestinal ulceration.
* Subject has active neoplastic disease or history of neoplastic disease.
* Subject has a concomitant diagnosis of any other inflammatory condition.
* Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Screening (D-28) until final study visit (Week 44)
measure: Change from Baseline 2 in DAS28(CRP)
timeFrame: Week 20
Secondary outcomes:
measure: Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2
timeFrame: Week 20
measure: ACR20 response based on Baseline 2
timeFrame: Week 20
measure: ACR50 response based on Baseline 2
timeFrame: Week 20
measure: ACR70 response based on Baseline 2
timeFrame: Week 20
measure: DAS28(CRP) remission
timeFrame: Week 20
Other outcomes:
Locations:
city: Praha 7
country: Czechia
facility: Ra0123 101
city: Balatonfured
country: Hungary
facility: Ra0123 203
city: Budapest
country: Hungary
facility: Ra0123 201
city: Budapest
country: Hungary
facility: Ra0123 202
city: Budapest
country: Hungary
facility: Ra0123 204
city: Chisinau
country: Moldova, Republic of
facility: Ra0123 801
city: Bialystok
country: Poland
facility: Ra0123 303
city: Lublin
country: Poland
facility: Ra0123 306
city: Poznan
country: Poland
facility: Ra0123 304
city: Poznan
country: Poland
facility: Ra0123 305
city: Warszawa
country: Poland
facility: Ra0123 301
city: Moscow
country: Russian Federation
facility: Ra0123 403
city: Moscow
country: Russian Federation
facility: Ra0123 404
city: Moscow
country: Russian Federation
facility: Ra0123 405
city: Moscow
country: Russian Federation
facility: Ra0123 406
city: Moscow
country: Russian Federation
facility: Ra0123 408
city: Saint Petersburg
country: Russian Federation
facility: Ra0123 407
city: Yaroslavl
country: Russian Federation
facility: Ra0123 402
city: Yaroslavl
country: Russian Federation
facility: Ra0123 410
city: Bratislava
country: Slovakia
facility: Ra0123 501
city: Glasgow
country: United Kingdom
facility: Ra0123 601
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Glatt S, Taylor PC, McInnes IB, Schett G, Landewe R, Baeten D, Ionescu L, Strimenopoulou F, Watling MIL, Shaw S. Efficacy and safety of bimekizumab as add-on therapy for rheumatoid arthritis in patients with inadequate response to certolizumab pegol: a proof-of-concept study. Ann Rheum Dis. 2019 Aug;78(8):1033-1040. doi: 10.1136/annrheumdis-2018-214943. Epub 2019 Jun 8.