Clinical trial NCT02778399: A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Pelvic Pain
Endometriosis
Dysmenorrhea
Dyspareunia
Lead sponsor: ObsEva SA
Sponsor class: INDUSTRY
First posted: 2016-05-19
Enrollment: 328
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS)
timeFrame: From baseline to week 12
measure: 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
timeFrame: From baseline to week 12
measure: 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
timeFrame: From baseline to week 12
measure: Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS)
timeFrame: From baseline to week 12
measure: Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS)
timeFrame: From baseline to week 12
measure: Percentage of Subjects With Any Analgesics Use at Week 12
timeFrame: Up to week 12
measure: Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain
timeFrame: From baseline to week 12
measure: Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12
timeFrame: Up to week 12
measure: Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12
timeFrame: Up to week 12
measure: Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score
timeFrame: From baseline to week 12
measure: Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD)
timeFrame: From baseline up to week 24
measure: Number of Non Benign Endometrial Biopsies at Week 24
timeFrame: Week 24
measure: Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS)
timeFrame: From baseline up to week 24
measure: Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL
timeFrame: From baseline up to week 24
measure: Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL
timeFrame: From Baseline up to week 24
measure: Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides
timeFrame: From baseline up to week 24
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site reference ID 455
state: Arizona
city: Scottsdale
country: United States
facility: Site reference ID 439
state: Arizona
city: Arcadia
country: United States
facility: Site reference ID 462
state: California
city: Chino
country: United States
facility: Site reference ID 405
state: California
city: Huntington Park
country: United States
facility: Site reference ID 463
state: California
city: Northridge
country: United States
facility: Site refenrec ID 469
state: California
city: San Diego
country: United States
facility: Site reference ID 431
state: California
city: Tustin
country: United States
facility: Site reference ID 440
state: California
city: Denver
country: United States
facility: Site reference ID 474
state: Colorado
city: Lakewood
country: United States
facility: Site reference ID 450
state: Colorado
city: Longmont
country: United States
facility: Site reference ID 425
state: Colorado
city: Washington
country: United States
facility: Site reference ID 410
state: District of Columbia
city: Boca Raton
country: United States
facility: Site reference ID 457
state: Florida
city: Clearwater
country: United States
facility: Site reference ID 418
state: Florida
city: Gainesville
country: United States
facility: Site reference ID 437
state: Florida
city: Jensen Beach
country: United States
facility: Site reference ID 458
state: Florida
city: Miami Lakes
country: United States
facility: Site reference ID 420
state: Florida
city: Miami Springs
country: United States
facility: Site reference ID 441
state: Florida
city: Miami
country: United States
facility: Site reference ID 411
state: Florida
city: Miami
country: United States
facility: Site reference ID 424
state: Florida
city: Miami
country: United States
facility: Site reference ID 435
state: Florida
city: New Port Richey
country: United States
facility: Site reference ID 423
state: Florida
city: Tampa
country: United States
facility: Site reference ID 426
state: Florida
city: Wellington
country: United States
facility: Site reference ID 442
state: Florida
city: Atlanta
country: United States
facility: Site reference ID 428
state: Georgia
city: Atlanta
country: United States
facility: Site reference ID 459
state: Georgia
city: Nampa
country: United States
facility: Site reference ID 475
state: Idaho
city: Oak Brook
country: United States
facility: Site reference ID 465
state: Illinois
city: Shawnee Mission
country: United States
facility: Site reference ID 404
state: Kansas
city: Wichita
country: United States
facility: Site reference ID 456
state: Kansas
city: Marrero
country: United States
facility: Site reference ID 454
state: Louisiana
city: Metairie
country: United States
facility: Site reference ID 453
state: Louisiana
city: Glen Burnie
country: United States
facility: Site reference ID 478
state: Maryland
city: Fall River
country: United States
facility: Site reference ID 445
state: Massachusetts
city: Fall River
country: United States
facility: Site reference ID 471
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site reference ID 430
state: Michigan
city: Bay City
country: United States
facility: Site reference ID 409
state: Michigan
city: Saginaw
country: United States
facility: Site reference ID 468
state: Michigan
city: Saginaw
country: United States
facility: Site reference ID 473
state: Michigan
city: Southfield
country: United States
facility: Site reference ID 427
state: Michigan
city: Albuquerque
country: United States
facility: Site reference ID 421
state: New Mexico
city: New York
country: United States
facility: Site reference ID 466
state: New York
city: Greensboro
country: United States
facility: Site reference ID 436
state: North Carolina
city: Morehead City
country: United States
facility: Site reference ID 433
state: North Carolina
city: Dayton
country: United States
facility: Site reference ID 443
state: Ohio
city: Franklin
country: United States
facility: Site reference ID 472
state: Ohio
city: Tiffin
country: United States
facility: Site reference ID 415
state: Ohio
city: Westerville
country: United States
facility: Site reference ID 414
state: Ohio
city: Bryn Mawr
country: United States
facility: Site reference ID 419
state: Pennsylvania
city: Jenkintown
country: United States
facility: Site reference ID 449
state: Pennsylvania
city: Columbia
country: United States
facility: Site reference ID 476
state: South Carolina
city: Bristol
country: United States
facility: Site reference ID 408
state: Tennessee
city: Chattanooga
country: United States
facility: Site reference ID 403
state: Tennessee
city: Nashville
country: United States
facility: Site reference ID 429
state: Tennessee
city: Austin
country: United States
facility: Site reference ID 452
state: Texas
city: Beaumont
country: United States
facility: Site reference ID 461
state: Texas
city: Dallas
country: United States
facility: Site reference ID 447
state: Texas
city: Dallas
country: United States
facility: Site reference ID 460
state: Texas
city: Fort Worth
country: United States
facility: Site reference ID 464
state: Texas
city: Houston
country: United States
facility: Site reference ID 413
state: Texas
city: Houston
country: United States
facility: Site reference ID 434
state: Texas
city: Houston
country: United States
facility: Site reference ID 479
state: Texas
city: San Antonio
country: United States
facility: Site reference ID 451
state: Texas
city: Schertz
country: United States
facility: Site reference ID 402
state: Texas
city: Webster
country: United States
facility: Site reference ID 432
state: Texas
city: Draper
country: United States
facility: Site reference ID 422
state: Utah
city: Centreville
country: United States
facility: Site reference ID 467
state: Virginia
city: Norfolk
country: United States
facility: Site reference ID 407
state: Virginia
city: Richmond
country: United States
facility: Site reference ID 412
state: Virginia
city: Richmond
country: United States
facility: Site reference ID 417
state: Virginia
city: Seattle
country: United States
facility: Site reference ID 406
state: Washington
city: Katowice
country: Poland
facility: Site reference ID 101
city: Katowice
country: Poland
facility: Site reference ID 102
city: Lublin
country: Poland
facility: Site reference ID 104
city: Lublin
country: Poland
facility: Site reference ID 105
city: Szczecin
country: Poland
facility: Site reference ID 103
city: Moscow
country: Russian Federation
facility: Site reference ID 201
city: Moscow
country: Russian Federation
facility: Site reference ID 202
city: Moscow
country: Russian Federation
facility: Site reference ID 203
city: Moscow
country: Russian Federation
facility: Site reference ID 204
city: Saint Petersburg
country: Russian Federation
facility: Site reference ID 205
city: Ivano-Frankivs'k
country: Ukraine
facility: Site reference ID 305
city: Kyiv
country: Ukraine
facility: Site reefrence ID 303
city: Kyiv
country: Ukraine
facility: Site reference ID 301
city: Kyiv
country: Ukraine
facility: Site reference ID 302
city: Kyiv
country: Ukraine
facility: SIte reference ID 304
Study officials:
affiliation: Geneva
name: ObsEva SA
role: STUDY_DIRECTOR
References:
citation: 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.