PGL5001 Proof of Concept Study in Inflammatory Endometriosis

NCT01630252 | Completed Phase 2 DMC

• 1 other identifier: PGL11-021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 8, week 20

Study Arms (5)

Part A2 - Active Treatment arm

ACTIVE COMPARATOR

PGL5001 for 8 weeks + one DMPA injection

Drug: PGL5001

Part A2 - Placebo Treatment arm

PLACEBO COMPARATOR

PGL5001 matching placebo for 8 weeks + one DMPA injection

Drug: Placebo

Part B - Active treatment arm

ACTIVE COMPARATOR

PGL5001 for 20 weeks + two DMPA injections

Drug: PGL5001

Part B - Placebo Treatment arm

PLACEBO COMPARATOR

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

Drug: Placebo

Part A1 - Active Treatment arm

EXPERIMENTAL

PGL5001 for 8 weeks + one unique DMPA 150 mg injection

Drug: PGL5001

Interventions

PGL5001 DRUG

PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

Part A2 - Active Treatment arm

Placebo DRUG

PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection

Part A2 - Placebo Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• PregLem SA: lead

Study Sites (1)

Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.

Bialystok, 15-224, Poland

Location

MeSH Terms

Conditions

Endometriosis

Interventions

bentamapimod

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Elke Bestel, MD

  PregLem SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

PL (1)