NL-OMON50087已完成2 期
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects with Moderate to Severe Hidradenitis Supperativa. - M16-833
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 15
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must be >= 18 years old at Screening with a clinical diagnosis
- •of moderate to severe HS (defined as a total AN count of >= 5 at Baseline,
- •presence of HS lesions in at least 2 distinct anatomic areas, and draining
- •fistula count of <= 20 at Baseline) for at least 1 year prior to Baseline, as
- •determined by the investigator (i.e., through medical history, interview
- •of subject).
- •Subjects must have a history of inadequate response or intolerance to
- •an adequate trial of oral antibiotics for treatment of HS.
- •Prior exposure to anti-IL12/23/17 (overall, no more than 10% of the
- •study population)
- •Prior exposure to anti-TNF (overall, no more than 15% of the study
- •population)
排除标准
- •No history of active skin disease other than HS that could interfere with
- •the assessment of HS.
- •No active TB or concurrent treatment for latent TB and no evidence of
- •HBV, HCV or HIV.
研究者
相似试验
已完成
2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects with Multiple OsteochondromasNL-OMON48469Clementia Pharmaceuticals Inc10
已完成
不适用
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First in Man, Single Escalating Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GAL-475 in Healthy Male Volunteers and Male Subjects with Sleep Apneasleep disorderSleep apneaNL-OMON55229eurim Pharmaceuticals Ltd.36
已完成
不适用
A phase I, randomised, double-blind, placebo-controlled study in patients with amyotrophic lateral sclerosis to further assess the safety and tolerability of intracerebroventricular administration of sNN0029 infusion solution.ALSLou Gehrig's disease1002930510009720NL-OMON40611ewron Sweden AB9
已完成
不适用
A phase I randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of NPT189 in healthy subjectsAmyloidosisNL-OMON48151Proclara Biosciences, Inc.24
已完成
2 期
Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)kidney diseaseADPKD10038430NL-OMON50604Sanofi-aventis32