A MULTICENTER, PHASE 2A, RANDOMIZED, INVESTIGATOR-BLIND, SUBJECT-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB AND CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
- Conditions
- Bechterew's Diseasearthritis10003816
- Registration Number
- NL-OMON48835
- Lead Sponsor
- CB Pharma
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
To be eligible to participate in this study, all of the following criteria must
be met:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
approved written
Informed Consent form is signed and dated by the subject.
2. Subject is considered reliable and capable of adhering to the protocol (eg,
able to understand
and complete diaries), visit schedule, and medication intake according to the
judgment of the
Investigator.
3. Subject is male or female and at least 18 years of age.
4. Subject has a documented diagnosis of adult-onset 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.
5. Subject has moderate to severe active disease at the Screening Visit as
defined by each of the
following:
*BASDAI score *4
*Spinal pain score *4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item
2)
6. Subject must have had an inadequate response to, have a contraindication to,
or has been
intolerant to at least 2 NSAIDs (inadequate response to an NSAID is defined as
lack of
response to at least 14 days of continuous NSAID therapy at the highest
tolerated dose of the
administered NSAID).
7. Subject may not have been exposed to more than 1 TNF antagonist prior to the
Baseline Visit
and may not be a primary failure to any TNF antagonist therapy (defined as no
response
within the first 12 weeks of treatment with the TNF antagonist.
8. Subject has hs-CRP levels above the ULN at the Screening Visit. One re-test
of hs-CRP is
permitted during the Screening Period upon discretion of the Investigator.
9. Female subjects must be postmenopausal (at least 1 year; to be confirmed
hormonally as part
of the screening process, if less than 2 years since last menstrual period),
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 up till 20 weeks after last
administration of
IMP, and have a negative pregnancy test at Visit 1 (Screening) and immediately
prior to first
dose. The following methods are considered highly effective when used
consistently and
correctly.
*combined (estrogen and progestogen) hormonal contraception associated with
inhibition
of ovulation (oral, intravaginal or transdermal)
*progestogen-only hormonal contraception associated with inhibition of
ovulation (oral,
injectable, implantable)
*intrauterine device (IUD)
*intrauterine hormone-releasing system (IUS)
*bilateral tubal occlusion
*vasectomized partner (where postvasectomy testing had demonstrated sperm
clearance)
*sexual abstinence if it is in accordance with a subject*s preferred and common
lifestyle.
Subjects who use abstinence as a form of birth control must agree to abstain
from
heterosexual intercourse until 20 weeks after the final dose of IMP
(anticipated 5
half-lifes of bimekizumab). Study personnel must confirm the continued use of
abstinence is still in accordance with the subject*s lifestyle at regular
intervals during the
study.
Male subjects with a partner of childbearing potential must be willing
Subjects are not permitted to enroll in the study if any of the following
criteria is met:
1. Female subject who is breastfeeding, pregnant, or planning to become
pregnant during the
study or within 20 weeks following final dose of study drug. Male subject who
is planning a
partner pregnancy during the study or within 20 weeks following the final dose.
2. Subject who has previously received bimekizumab or CZP.
3. Subject has participated in another study of a medication under
investigation within the last 3
months or at least 5 half-lives of the IMP, whichever is greater, or is
currently participating in
another study of a medication under investigation.
4. Subject has a known hypersensitivity to any excipients of bimekizumab or CZP.
5. Subject has received previous treatment with a polyethylene glycolylated
(PEGylated)
compound that resulted in a severe hypersensitivity reaction or an anaphylactic
reaction
6. Subject has a total ankylosis of the spine or a diagnosis of any other
inflammatory arthritis
eg, RA, systemic lupus erythematosus, sardoidosis, psoriatic arthritis, or
reactive arthritis.
Subjects with a diagnosis of Crohn*s disease or ulcerative colitis are allowed
as long as they
have no active symptomatic disease at Screening or Baseline.
7. Subject has a secondary, noninflammatory condition (eg, osteoarthritis,
fibromyalgia) that in
the Investigator*s opinion is symptomatic enough to interfere with evaluation
of the effect of
study drug on the subject*s primary diagnosis of active AS.
8. Subject has received previous or current biological treatment other than
TNF* inhibitor
treatment.
9. Subjects must not have used medications
10. Subject has:
*a history of chronic or recurrent infections (eg, more than 3 episodes
requiring systemic
antibiotics or antivirals during the preceding year). Minor illnesses like
common cold or
transient, localized infections that may have been treated with a short course
of antibiotic
therapy (up to 7 days) need not count in this assessment.
*a serious or life-threatening infection within the 6 months prior to the
Baseline Visit
(including herpes zoster) or hospitalization for any infection in the last 6
months.
*any current sign or symptom that may indicate an active infection (except for
common
cold), or has had an infection requiring systemic antibiotics within 2 weeks
prior to
Baseline.
*a high risk of infection in the Investigator*s opinion (eg, subjects with leg
ulcers,
indwelling urinary catheter, prior prosthetic joint infection at any time,
subjects who are
permanently bedridden or wheelchair assisted).
11. Subject has a history of or current clinically active infection with
Histoplasma, Coccidiodes,
Paracoccidioides, Pneumocystis, nontuberculous mycobacteria (NTMB),
Blastomyces, or
Aspergillus or current active Candidiasis (local or systemic)
12. Subject has acute or chronic viral hepatitis B or C or human
immunodeficiency virus (HIV)
infection. Subjects who have evidence of, or test positive for, hepatitis B or
hepatitis C are
excluded as follows:
*A positive test for the hepatitis B virus (HBV) is defined as: 1) positive for
hepatitis B
surface antigen (HBsAg+), or 2) positive for anti-hepatitis B core antibody
(HBcAb+).
*A positive test for the hep
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable for this study is as follows:<br /><br>*Change from Baseline in ASDAS at Week 12</p><br>
- Secondary Outcome Measures
Name Time Method