临床试验/NCT01630252

NCT01630252已完成2 期

A Phase IIa Efficacy and Safety Study of PGL5001 Versus Placebo Administered for up to 5 Months With Concomitant Administration of Depot Medroxyprogesterone Acetate for the Treatment of Peritoneal and/or Ovarian Endometriosis With an Inflammatory Component.

PregLem SA1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2012年6月最近更新: 2014年6月3日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: PregLem SA
入组人数: 24
试验地点: 1
主要终点: Change from baseline to end of treatment in the number and percentage of red lesions (and/or inflammatory lesions), based on total number of red and black lesions.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001 orally administered for up to 5 months with concomitant DMPA administration for the treatment of laparoscopically diagnosed inflammatory endometriosis. The part A1 is open-label, the parts A2 and B are double-blind.

The target population will be women of reproductive age and suffering from newly diagnosed peritoneal and/or ovarian endometriosis.

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: Female
接受健康志愿者: 否

入选标准

•The Subject must provide written informed consent prior to initiation of any study related procedures.
•The Subject must be an adult woman of reproductive age, aged from 18 and above.
•The Subject must be a newly diagnosed patient suffering from peritoneal and/or ovarian endometriosis with at least 15% of the endometriotic lesions observed at the study diagnostic laparoscopy being red inflammatory lesions and with a proven histological diagnosis.
•The Subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end.
•The Subject must have a history of pelvic pain for at least 3 months prior to the screening visit.

排除标准

•The Subject is over 40 years old and has a FSH serum level during Day 2-4 of her cycle ≥ 21.5 mIU/ml.
•The Subject has a positive pregnancy test at baseline or is breast-feeding or planning a pregnancy during the course of the study.
•The Subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
•The Subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy.
•The Subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy.
•The Subject has a history (in the past 12 months) of or a current medical treatment for endometriosis other than NSAID (e.g. GnRH agonist or antagonist, danazol, continuous oral combined oestroprogestogens).

研究组 & 干预措施

Part A2 - Active Treatment arm

Active Comparator

PGL5001 for 8 weeks + one DMPA injection

干预措施: PGL5001 (Drug)

Part A2 - Placebo Treatment arm

Placebo Comparator

PGL5001 matching placebo for 8 weeks + one DMPA injection

干预措施: Placebo (Drug)

Part B - Active treatment arm

Active Comparator

PGL5001 for 20 weeks + two DMPA injections

干预措施: PGL5001 (Drug)

Part B - Placebo Treatment arm

Placebo Comparator

PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections

干预措施: Placebo (Drug)

Part A1 - Active Treatment arm

Experimental

PGL5001 for 8 weeks + one unique DMPA 150 mg injection

干预措施: PGL5001 (Drug)

结局指标

主要结局

Change from baseline to end of treatment in the number and percentage of red lesions (and/or inflammatory lesions), based on total number of red and black lesions.

时间窗: at week 8, week 20

次要结局

未报告次要终点

研究者

发起方

PregLem SA

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

招募中

1 期

A Phase 2 Study on Narsoplimab in Paediatric Patients with High Risk Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy

CTIS2023-509710-11-00Omeros Corp.18

招募中

2 期

A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant Thrombotic Microangiopathythrombotic microangiopathies (TMA)100188651002766510047066

NL-OMON56242Omeros Corporation2

进行中（未招募）

1 期

A Phase 2 Study on Narsoplimab in Paediatric Patients with High Risk Haematopoietic Stem Cell Transplant Thrombotic MicroangiopathyThrombotic microangiopathies following haematopoietic stem cell transplantMedDRA version: 20.0Level: HLGTClassification code 10064477Term: Coagulopathies and bleeding diatheses (excl thrombocytopenic)System Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: PTClassification code 10043645Term: Thrombotic microangiopathySystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLTClassification code 10053567Term: CoagulopathiesSystem Organ Class: 10005329 - Blood and lymphatic system disorders

EUCTR2021-002727-38-HUOmeros Corporation18

进行中（未招募）

1 期

EUCTR2021-002727-38-DEOmeros Corporation18

进行中（未招募）

1 期

Clinical study to review how safe and how effective IMR-687 is in subjects with Sickle Cell DiseaseMedDRA version: 20.0Level: PTClassification code 10043395Term: Thalassaemia sickle cellSystem Organ Class: 10010331 - Congenital, familial and genetic disordersSickle Cell Disease

EUCTR2019-004471-39-ITIMARA Inc.99