A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS

CB Biopharma SPR0 个研究点目标入组 300 人开始时间: 2019年5月21日最近更新: 2020年6月22日

适应症

试验速览

暂无简介。

•-Male or female patients at least 18 years of age
•-Subject has ankylosing spondylitis as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years
•-Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale
•-Patients must have inadequate response to NSAIDs, intolerance to administration of at least 1 NSAID, or contraindication(s) to NSAID therapy
•-Patients who have taken a tumor necrosis factor alpha (TNFa) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
•-Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
•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 288
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•-Total ankylosis of the spine
•-Treatment with more than 1 TNFa inhibitor and/or more than 2 additional non-TNFa biological response modifiers, or any interleukin (IL)-17 biological response modifier at any time are excluded
•-Active infection or history of recent serious infections
•-Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
•-Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
•-Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
•-Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer
•-Diagnosis of inflammatory conditions other than AxSpA, eg, rheumatoid arthritis. Patients with a diagnosis of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study
•-Presence of active suicidal ideation, or moderately severe major depression or severe major depression
•-Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
•-Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

发起方

CB Biopharma SPR