A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis

• Register: EUCTR
• Last refreshed on: 11 May 2020
• Main ID: EUCTR2017-001002-15-CZ
• Date of registration: 29/08/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis
• Scientific title: A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis
• Date of first enrolment: 01/11/2017
• Target sample size: 285
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001002-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Czech Republic, Germany, Hungary, Spain

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- In the opinion of the Investigator, the subject is expected to benefit
from participation in an Open Label Extension (OLE) study.
- Subject completed AS0008 without meeting any withdrawal criteria.
- Female subjects must be postmenopausal, permanently sterilized or, if
of childbearing potential, must be willing to use a highly effective
method of contraception.
- Male subjects with a partner of childbearing potential must be willing
to use a condom when sexually active.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion criteria:
- Female subjects who plan to become pregnant during the study or
within 20 weeks following the last dose of investigational medicinal
product (IMP). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose.
- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry.
- Subjects who meet any withdrawal criteria in AS0008. For any subject
with an ongoing Serious Adverse Event, or a history of serious infections
(including hospitalizations) in the lead-in study, the Medical Monitor
must be consulted prior to the subject's entry into AS0009.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ankylosing Spondylitis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BIMEKIZUMAB
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1-2. From Entry Visit (Visit 1) until Last Visit (up to Week 208)

Main Objective: Assess the long-term safety and tolerability of bimekizumab
administered over a period of up to 4 years.

Primary end point(s): 1. Incidence of Treatment-Emergent Adverse Events (TEAEs) during the study
2. Incidence of Serious Adverse Event (SAE) during the study

Secondary Objective: Assess the long-term efficacy of bimekizumab.

Secondary Outcome(s)

Secondary end point(s): 3. Subjects who withdrew due to a Treatment-Emergent Adverse Event (TEAE) during the study
4. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008
5. Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008
6. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48

Timepoint(s) of evaluation of this end point: 3: From Entry Visit (Visit 1) until Last Visit (up to Week 208)
4-6: Baseline of AS0008, Week 48

Secondary ID(s)

AS0009

2017-001002-15-HU

NCT03355573

Source(s) of Monetary Support

UCB Biopharma SRL

Ethics review

Status: Approved
Approval date: 13/09/2017
Contact: