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

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ClinicalTrials.gov Identifier: NCT02778399
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

Tracking Information
First Submitted Date  ICMJE May 3, 2016
First Posted Date  ICMJE May 19, 2016
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
Endometriosis associated pelvic pain score [ Time Frame: From baseline to week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Endometriosis associated pelvic pain scores [ Time Frame: From baseline up to week 36 ]
  • Endometriosis associated pelvic pain scores for days with uterine bleeding [ Time Frame: From baseline up to week 36 ]
  • Endometriosis associated pelvic pain scores for days with no uterine bleeding [ Time Frame: From baseline up to week 36 ]
  • Dyspareunia score [ Time Frame: Up to week 36 ]
  • Dyschezia score [ Time Frame: Up to week 36 ]
  • Use of analgesics [ Time Frame: Up to week 36 ]
  • Endometriosis Health Profile-30 (EHP-30) score [ Time Frame: Up to week 36 ]
  • Patient Global Impression of Change (PGIC) score [ Time Frame: Up to week 36 ]
  • Patient status score [ Time Frame: Up to week 36 ]
  • Modified Biberoglu & Behrman (mB&B) score [ Time Frame: Up to week 36 ]
    The severity of subject reported pain symptoms of endometriosis and physician findings of endometriosis according to the mB&B scale.
  • Difficulty in doing daily activities score [ Time Frame: Up to week 36 ]
  • Bone Mineral Density (BMD) [ Time Frame: From baseline up to week 48 ]
    Change from baseline up to week 48 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan.
  • Endometrial biopsies [ Time Frame: From baseline up to week 36 ]
    Any pathological changes from baseline in the endometrium assessed by histology from endometrial biopsies.
  • Transvaginal ultrasound (TVUS) endometrial thickness [ Time Frame: From baseline up to week 36 ]
    Any pathological changes from baseline in the endometrium.
  • Adverse events [ Time Frame: Up to week 48. ]
    Treatment emergent adverse events frequency and severity.
  • Clinical laboratory assessments and vital signs [ Time Frame: From baseline up to week 36 ]
    Change from baseline in clinical laboratory assessments and vital signs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: Placebo
    Placebo tablets for oral administration once daily
  • Drug: OBE2109
    OBE2109 tablets for oral administration once daily
Study Arms  ICMJE
  • Experimental: OBE2109 dose 1
    Intervention: Drug: OBE2109
  • Experimental: OBE2109 dose 2
    Intervention: Drug: OBE2109
  • Experimental: OBE2109 dose 3
    Intervention: Drug: OBE2109
  • Experimental: OBE2109 dose 4
    Intervention: Drug: OBE2109
  • Experimental: OBE2109 dose 5
    Intervention: Drug: OBE2109
  • Placebo Comparator: Placebo / OBE2109 dose 6
    Interventions:
    • Drug: Placebo
    • Drug: OBE2109
Publications * Donnez J, Taylor HS, Taylor RN, Akin MD, Tatarchuk TF, Wilk K, Gotteland JP, Lecomte V, Bestel E. Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial. Fertil Steril. 2020 Jul;114(1):44-55. doi: 10.1016/j.fertnstert.2020.02.114. Epub 2020 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2019)
328
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)
330
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02778399
Other Study ID Numbers  ICMJE 15-OBE2109-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ObsEva SA
Study Sponsor  ICMJE ObsEva SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ObsEva SA Geneva
PRS Account ObsEva SA
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP