NL-OMON48835已完成2 期
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 - AS0013
CB Pharma0 个研究点目标入组 1 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, all of the following criteria must
- •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
- •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
- •*BASDAI score *4
- •*Spinal pain score *4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item
- •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
- •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
- •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
- •*combined (estrogen and progestogen) hormonal contraception associated with
- •of ovulation (oral, intravaginal or transdermal)
- •*progestogen-only hormonal contraception associated with inhibition of
- •ovulation (oral,
- •injectable, implantable)
- 另有 12 项未显示
排除标准
- •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
- •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
- •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
- •*any current sign or symptom that may indicate an active infection (except for
- •cold), or has had an infection requiring systemic antibiotics within 2 weeks
- •*a high risk of infection in the Investigator*s opinion (eg, subjects with leg
- •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
- 另有 13 项未显示
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