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PGL5001 Proof of Concept Study in Inflammatory Endometriosis (JADE)

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

PGL5001

Placebo

PGL5001

Placebo

PGL5001

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Experimental

Arm Label

Part A2 - Active Treatment arm

Part A2 - Placebo Treatment arm

Part B - Active treatment arm

Part B - Placebo Treatment arm

Part A1 - Active Treatment arm

Arm Description

PGL5001 for 8 weeks + one DMPA injection

PGL5001 matching placebo for 8 weeks + one DMPA injection

PGL5001 for 20 weeks + two DMPA injections

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

PGL5001 for 8 weeks + one unique DMPA 150 mg injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01630252

First Posted

June 26, 2012

Last Updated

June 2, 2014

Sponsor

PregLem SA

1. Study Identification

Unique Protocol Identification Number

NCT01630252

Brief Title

PGL5001 Proof of Concept Study in Inflammatory Endometriosis

Acronym

JADE

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PregLem SA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A2 - Active Treatment arm

Arm Type

Active Comparator

Arm Description

PGL5001 for 8 weeks + one DMPA injection

Arm Title

Part A2 - Placebo Treatment arm

Arm Type

Placebo Comparator

Arm Description

PGL5001 matching placebo for 8 weeks + one DMPA injection

Arm Title

Part B - Active treatment arm

Arm Type

Active Comparator

Arm Description

PGL5001 for 20 weeks + two DMPA injections

Arm Title

Part B - Placebo Treatment arm

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Part A1 - Active Treatment arm

Arm Type

Experimental

Arm Description

PGL5001 for 8 weeks + one unique DMPA 150 mg injection

Intervention Type

Drug

Intervention Name(s)

PGL5001

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PGL5001

Intervention Description

PGL5001 320mg/day (160 mg twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection

Intervention Type

Drug

Intervention Name(s)

PGL5001

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

at week 8, week 20

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elke Bestel, MD

Organizational Affiliation

PregLem SA

Official's Role

Study Director

Facility Information:

Facility Name

Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.

City

Bialystok

ZIP/Postal Code

15-224

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

PGL5001 Proof of Concept Study in Inflammatory Endometriosis

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