A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ACTIVE REFERENCE (ADALIMUMAB) STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN THE TREATMENT OF SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS - BE OPTIMA

CB Biopharma SPR0 个研究点目标入组 852 人开始时间: 2019年4月12日最近更新: 2023年10月16日

适应症

试验速览

暂无简介。

•- Subject is male or female at least 18 years of age
•- Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
•- Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
•- Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
•- Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
•- Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
•- Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), 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 754
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 86

•- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
•- Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
•- Subject has an active infection or a history of recent serious infections
•- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
•- Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects 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 at Screening or Baseline
•- Subject had acute anterior uveitis within 6 weeks of Baseline
•- 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
•- Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
•- Presence of active suicidal ideation, or moderately severe major depression or severe major depression
•- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

发起方

CB Biopharma SPR