Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 October 2017 |
Main ID: |
EUCTR2017-001002-15-HU |
Date of registration:
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29/08/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Evaluate the Long Term Safety and Efficacy of
Bimekizumab in Subjects with Ankylosing Spondylitis
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Scientific title:
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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:
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25/10/2017 |
Target sample size:
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285 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001002-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Hungary
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Contacts
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Name:
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Clin Trial Reg & Results Disclosure
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Address:
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Alfred-Nobel-Strasse 10
40789
Monheim
Germany |
Telephone:
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Email:
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clinicaltrials@ucb.com |
Affiliation:
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UCB Biosciences GmbH |
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Name:
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Clin Trial Reg & Results Disclosure
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Address:
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Alfred-Nobel-Strasse 10
40789
Monheim
Germany |
Telephone:
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Email:
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clinicaltrials@ucb.com |
Affiliation:
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UCB Biosciences GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative.
- Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
- 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.
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative.
- Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
- Female subjects must be postmenopausal, permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception until 20 weeks after last administration of IMP, and have a negative pregnancy test at the last visit of AS0008.
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active , up until 20 weeks after the last administration of IMP (anticipated 5 half lives). 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 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
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis MedDRA version: 20.0
Level: PT
Classification code 10002556
Term: Ankylosing spondylitis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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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-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1-2. From Entry Visit (Visit 1) until Last Visit (up to Week 208)
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Primary end point(s): 1. Incidence of Adverse Event (AE) during the study 2. Incidence of Serious Adverse Event (SAE) during the study
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Secondary Objective: Assess the long-term efficacy of bimekizumab.
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Main Objective: Assess the long-term safety and tolerability of bimekizumab administered over a period of up to 4 years.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 3: From Entry Visit (Visit 1) until Last Visit (up to Week 208)
4, 6, 8: Baseline of AS0008, Week 48
5, 7, 9: AS0009 Entry Visit, Week 48
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Secondary end point(s): 3. Subjects who withdrew due to an Adverse Event (AE) during the study
4. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline
5. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to AS0009 entry value
6. Subjects with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 48 calculated relative to Baseline
7. Subjects with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 48 calculated relative to AS0009 entry value
8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
9. Change from AS0009 entry value in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
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Source(s) of Monetary Support
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UCB Biopharma SPRL
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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