Phase 2
N=328
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT02778399 ↗Enrolled (actual)
328
Serious AEs
1.6%
Results posted
Jul 2022
Primary outcome: Primary: Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS) — 34.5; 49.4; 61.5; 56.4 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); OBE2109 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- ObsEva SA
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS) |
34.5; 49.4; 61.5; 56.4; 56.3 | — |
| SECONDARY Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS) |
-1.17; -1.75; -2.15; -2.06; -2.14 | — |
| SECONDARY Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With Uterine Bleeding |
28.5; 43.3; 68.2; 68.6; 78.9 | — |
| SECONDARY Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With no Uterine Bleeding |
37.1; 46.2; 58.5; 61.5; 47.7 | — |
| SECONDARY Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS) |
-0.39; -0.62; -0.59; -0.66; -0.79 | — |
| SECONDARY Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS) |
-0.78; -1.55; -1.87; -1.97; -1.7 | — |
| SECONDARY Percentage of Subjects With Any Analgesics Use at Week 12 |
90.6; 77.1; 74.8; 68.8; 72.1 | — |
| SECONDARY Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain |
-7.4; -18.5; -18.9; -19.4; -20.9 | — |
| SECONDARY Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12 |
65.1; 78.6; 80.6; 86; 95.7 | — |
| SECONDARY Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12 |
20.9; 4.5; 7.8; 4.5; 4.2 | — |
| SECONDARY Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score |
-1.17; -1.65; -2.06; -1.88; -1.99 | — |
| SECONDARY Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD) |
-0.929; 0.137; -0.798; -1.000; -1.365; -2.602 | — |
| SECONDARY Number of Non Benign Endometrial Biopsies at Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) |
-3.1; -1.5; -2.3; -1.3; -1.6; -4.0 | — |
| SECONDARY Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL |
1.7; -0.3; 7.4; 7.3; 9.7; 10.3 | — |
| SECONDARY Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL |
5.5; 2.9; 3.8; 6.2; 5.6; 8.1 | — |
| SECONDARY Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides |
17.9; 16.4; 5.2; 13.6; 20.5; 24.0 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02778399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.