PGL5001 Proof of Concept Study in Inflammatory Endometriosis (JADE)

PregLem

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: PGL5001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01630252

PGL11-021

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 5 patient groups, including a placebo group

Part A2 - Active Treatment arm

Active Comparator group

Description:

PGL5001 for 8 weeks + one DMPA injection

Treatment:

Drug: PGL5001

Drug: PGL5001

Drug: PGL5001

Part A2 - Placebo Treatment arm

Placebo Comparator group

Description:

PGL5001 matching placebo for 8 weeks + one DMPA injection

Treatment:

Drug: Placebo

Drug: Placebo

Part B - Active treatment arm

Active Comparator group

Description:

PGL5001 for 20 weeks + two DMPA injections

Treatment:

Drug: PGL5001

Drug: PGL5001

Drug: PGL5001

Part B - Placebo Treatment arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

Part A1 - Active Treatment arm

Experimental group

Description:

PGL5001 for 8 weeks + one unique DMPA 150 mg injection

Treatment:

Drug: PGL5001

Drug: PGL5001

Drug: PGL5001