BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

A Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Oral BGS649 Monotherapy Assessing Safety and Tolerability in Patients With Moderate to Severe Endometriosis

This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Active treatment with a high dose of BGS649; Drug: Active treatment with a low dose of BGS649; Drug: Placebo treatment to blind study

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Premenopausal women with documented moderate to severe endometriosis. Occurrence of three sequential menstrual cycles of 24-35 days duration prior to enrollment.
• Laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed within the past 10 years before screening).
• Patients not planning to become pregnant within one year after the screening visit and willing to use two effective methods of non-hormonal, barrier birth control for the duration of the study or who are surgically sterile.
• Patients must have a score of at least 4 on the numerical rating scale (NRS) for one of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia

Exclusion Criteria:

• Estrogen replacement therapy using either prescription medications or estrogen-containing OTC nutritional/herbal supplements such as soy extracts or topical estrogens.
• Aromatase inhibitor therapy (includes Femara (letrozole), Aromasin (exemestane) or Arimidex (anastrozole) within the past 12 months.
• Oral bisphosphonate therapy (i.e. Fosamax (alendronate)) within the past 6 months or intravenous bisphosphonate (i.e., Reclast, pamidronate) < 15 months from screening.
• Systemic glucocorticoid therapy within the past 4 weeks.
• Contra-indications to oral contraceptive use.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGS649 high dose; 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.	Drug: Active treatment with a high dose of BGS649
Experimental: BGS649 low dose; 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules	Drug: Active treatment with a low dose of BGS649
Placebo Comparator: Placebo to BGS649; 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules	Drug: Placebo treatment to blind study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger	Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Profille of BGS649 as Described by AUC0-672h	AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.	8 hours
Pharmacokinetic Profile of BGS649 as Described by Cmax	The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.	8 hours
Pharmacokinetic Profile of BGS649 as Described by Tmax	Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose.	8 hours

Collaborators and Investigators

• Sponsor: Mereo BioPharma
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 26, 2010
• First Posted (Estimate): August 27, 2010

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Infertility; Endometriosis; Uterine Diseases; Vaginal Diseases
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: CBGS649A2105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO