NCT07830329尚未招募2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 52-Week Trial to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Percent change in total Abscess and inflammatory Nodule (AN) count
研究概览
简要总结
This study will test an experimental Regeneron drug called olatorepatide ("study drug") to see if it can help treat Hidradenitis Suppurativa (HS).
In this study, olatorepatide is being tested in people with HS and living with overweight or obesity to see if it helps improve their HS symptoms and quality of life and helps support weight loss.
The study is looking at:
- What side effects olatorepatide might cause
- How well olatorepatide works
- How much olatorepatide is in the blood at different times
- If the body makes antibodies to olatorepatide, which may cause olatorepatide to not work as well
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HS based on:
- •Documented or reported history of HS for ≥6 months prior to baseline visit
- •Confirmation of HS by the investigator during physical examination at screening
- •HS lesions present in at least 2 distinct anatomic areas as described in the protocol
- •Moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both screening (visit 1) and baseline (visit 2)
- •Agree to daily use of over-the-counter topical antiseptics (eg, chlorhexidine gluconate, benzoyl peroxide, or diluted bleach [bath], or alternative antiseptic agents in accordance with local/country guidelines) applied to HS-affected areas as described in the protocol
- •Body Mass Index (BMI) ≥27.0 kg/m2 at screening
排除标准
- •Has a sensitivity (or history of hypersensitivity reactions) to any of the trial interventions, or components thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the trial
- •Cardiovascular or cerebrovascular events or procedures within 90 days prior to screening, including myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention as described in the protocol
- •Current heart failure classified as being in NYHA Class IV at screening
- •History of chronic pancreatitis or acute pancreatitis
- •Presence of serious Gastrointestinal (GI) disorders (eg, active peptic ulcer, inflammatory bowel disease) at screening
- •Have a previous or current diagnosis of Type 1 Diabetes (T1D) or any other type of diabetes except Type 2 Diabetes (T2D) as described in the protocol
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Olatorepatide
Experimental
干预措施: Olatorepatide (Drug)
结局指标
主要结局
Percent change in total Abscess and inflammatory Nodule (AN) count
时间窗: From baseline to week 52
次要结局
- Percent change in body weight(From baseline to week 52)
- Achieving HiSCR50 (≥50% reduction from baseline in total AN counts with no increase in abscess count and no increase in draining tunnel count)(At week 52)
- Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)(From baseline to week 52)
- Percent change in weekly average Skin Pain NRS(From baseline to week 52)
- Achieving ≥3-point reduction in weekly average Skin Pain NRS(From baseline to week 52)
- Absolute change in Dermatology Life Quality Index (DLQI)(From baseline to week 52)
- Achieving minimum clinically important difference (reduction of ≥4 points from baseline score) in the DLQI total score(At week 52)
- Absolute change in high-sensitivity C-Reactive Protein (hsCRP)(From baseline up to week 52)
- Percent change in hsCRP(From baseline up to week 52)
- Concentrations of olatorepatide(Up to week 56)
- Occurrence of Anti-Drug Antibodies (ADAs) to olatorepatide(Up to week 56)
- Magnitude of ADAs to olatorepatide(Up to week 56)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to week 56)
研究者
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