A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis (EDELWEISS)

ObsEva

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: OBE2109; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02778399

15-OBE2109-001

Details and patient eligibility

About

The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

Full description

The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain.

Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen).

Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.

Enrollment: 328 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
• The subject has moderate to severe endometriosis-associated pain during the screening period.
• The subject has regular menstrual cycles.
• The subject has a BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

• The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
• The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
• The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
• The subject has a history of, or known osteoporosis or other metabolic bone disease.
• The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 6 patient groups, including a placebo group

OBE2109 50 mg

Experimental group

Treatment:

Drug: OBE2109

OBE2109 75mg fixed dose (FD)

Experimental group

Treatment:

Drug: OBE2109

OBE2109 75mg titrated dose (TD)

Experimental group

Treatment:

Drug: OBE2109

OBE2109 100mg

Experimental group

Treatment:

Drug: OBE2109

OBE2109 200 mg

Experimental group

Treatment:

Drug: OBE2109

Placebo / OBE2109 100mg

Placebo Comparator group

Description:

Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.

Treatment:

Drug: OBE2109

Drug: Placebo