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

NCT02778399 | Completed Phase 2 Results DMC

• 1 other identifier: 15-OBE2109-001
• Study Type: interventional
• Target: 328
• Locations: 4 countries
• Sites: 86

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.

Conditions

Endometriosis

Keywords

Pelvic Pain; Endometriosis; Dysmenorrhea; Dyspareunia

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)

  The primary efficacy endpoint of the study was a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.

  From baseline to week 12

Secondary Outcomes (16)

• Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS)

  From baseline to week 12

• 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

  From baseline to week 12

• 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

  From baseline to week 12

• Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS)

  From baseline to week 12

• Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS)

  From baseline to week 12

Study Arms (6)

OBE2109 50 mg

EXPERIMENTAL

Drug: OBE2109

OBE2109 75mg fixed dose (FD)

EXPERIMENTAL

Drug: OBE2109

OBE2109 75mg titrated dose (TD)

EXPERIMENTAL

Drug: OBE2109

OBE2109 100mg

EXPERIMENTAL

Drug: OBE2109

OBE2109 200 mg

EXPERIMENTAL

Drug: OBE2109

Placebo / OBE2109 100mg

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: OBE2109

Interventions

Placebo DRUG

Placebo tablets for oral administration once daily

Placebo / OBE2109 100mg

OBE2109 DRUG

OBE2109 tablets for oral administration once daily

OBE2109 100mg; OBE2109 200 mg; OBE2109 50 mg; OBE2109 75mg fixed dose (FD); OBE2109 75mg titrated dose (TD); Placebo / OBE2109 100mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ObsEva SA: lead

Study Sites (86)

Site reference ID 455

Chandler, Arizona, United States

Location

Site reference ID 439

Scottsdale, Arizona, United States

Location

Site reference ID 462

Arcadia, California, United States

Location

Site reference ID 405

Chino, California, United States

Location

Site reference ID 463

Huntington Park, California, United States

Location

Site refenrec ID 469

Northridge, California, United States

Location

Site reference ID 431

San Diego, California, United States

Location

Site reference ID 440

Tustin, California, United States

Location

Site reference ID 474

Denver, Colorado, United States

Location

Site reference ID 450

Lakewood, Colorado, United States

Location

Site reference ID 425

Longmont, Colorado, United States

Location

Site reference ID 410

Washington D.C., District of Columbia, United States

Location

Site reference ID 457

Boca Raton, Florida, United States

Location

Site reference ID 418

Clearwater, Florida, United States

Location

Site reference ID 437

Gainesville, Florida, United States

Location

Site reference ID 458

Jensen Beach, Florida, United States

Location

Site reference ID 411

Miami, Florida, United States

Location

Site reference ID 424

Miami, Florida, United States

Location

Site reference ID 435

Miami, Florida, United States

Location

Site reference ID 420

Miami Lakes, Florida, United States

Location

Site reference ID 441

Miami Springs, Florida, United States

Location

Site reference ID 423

New Port Richey, Florida, United States

Location

Site reference ID 426

Tampa, Florida, United States

Location

Site reference ID 442

Wellington, Florida, United States

Location

Site reference ID 428

Atlanta, Georgia, United States

Location

Site reference ID 459

Atlanta, Georgia, United States

Location

Site reference ID 475

Nampa, Idaho, United States

Location

Site reference ID 465

Oak Brook, Illinois, United States

Location

Site reference ID 404

Shawnee Mission, Kansas, United States

Location

Site reference ID 456

Wichita, Kansas, United States

Location

Site reference ID 454

Marrero, Louisiana, United States

Location

Site reference ID 453

Metairie, Louisiana, United States

Location

Site reference ID 478

Glen Burnie, Maryland, United States

Location

Site reference ID 445

Fall River, Massachusetts, United States

Location

Site reference ID 471

Fall River, Massachusetts, United States

Location

Site reference ID 430

Ann Arbor, Michigan, United States

Location

Site reference ID 409

Bay City, Michigan, United States

Location

Site reference ID 468

Saginaw, Michigan, United States

Location

Site reference ID 473

Saginaw, Michigan, United States

Location

Site reference ID 427

Southfield, Michigan, United States

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Site reference ID 421

Albuquerque, New Mexico, United States

Location

Site reference ID 466

New York, New York, United States

Location

Site reference ID 436

Greensboro, North Carolina, United States

Location

Site reference ID 433

Morehead City, North Carolina, United States

Location

Site reference ID 443

Dayton, Ohio, United States

Location

Site reference ID 472

Franklin, Ohio, United States

Location

Site reference ID 415

Tiffin, Ohio, United States

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Site reference ID 414

Westerville, Ohio, United States

Location

Site reference ID 419

Bryn Mawr, Pennsylvania, United States

Location

Site reference ID 449

Jenkintown, Pennsylvania, United States

Location

Site reference ID 476

Columbia, South Carolina, United States

Location

Site reference ID 408

Bristol, Tennessee, United States

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Site reference ID 403

Chattanooga, Tennessee, United States

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Site reference ID 429

Nashville, Tennessee, United States

Location

Site reference ID 452

Austin, Texas, United States

Location

Site reference ID 461

Beaumont, Texas, United States

Location

Site reference ID 447

Dallas, Texas, United States

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Site reference ID 460

Dallas, Texas, United States

Location

Site reference ID 464

Fort Worth, Texas, United States

Location

Site reference ID 413

Houston, Texas, United States

Location

Site reference ID 434

Houston, Texas, United States

Location

Site reference ID 479

Houston, Texas, United States

Location

Site reference ID 451

San Antonio, Texas, United States

Location

Site reference ID 402

Schertz, Texas, United States

Location

Site reference ID 432

Webster, Texas, United States

Location

Site reference ID 422

Draper, Utah, United States

Location

Site reference ID 467

Centreville, Virginia, United States

Location

Site reference ID 407

Norfolk, Virginia, United States

Location

Site reference ID 412

Richmond, Virginia, United States

Location

Site reference ID 417

Richmond, Virginia, United States

Location

Site reference ID 406

Seattle, Washington, United States

Location

Site reference ID 101

Katowice, Poland

Location

Site reference ID 102

Katowice, Poland

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Site reference ID 104

Lublin, Poland

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Site reference ID 105

Lublin, Poland

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Site reference ID 103

Szczecin, Poland

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Site reference ID 201

Moscow, Russia

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Site reference ID 202

Moscow, Russia

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Site reference ID 203

Moscow, Russia

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Site reference ID 204

Moscow, Russia

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Site reference ID 205

Saint Petersburg, Russia

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Site reference ID 305

Ivano-Frankivsk, Ukraine

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Site reefrence ID 303

Kyiv, Ukraine

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Site reference ID 301

Kyiv, Ukraine

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Site reference ID 302

Kyiv, Ukraine

Location

SIte reference ID 304

Kyiv, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 32505383 DERIVED

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Dysmenorrhea; Dyspareunia

Interventions

linzagolix

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Results Point of Contact

• Title: Medical Responsible
• Organization: Clinical Operations

clinicaltrials@obseva.ch

+41 (0)22 552 1560

Study Officials

• ObsEva SA

  Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 19, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2019
• Last Updated: July 21, 2022
• Results First Posted: July 21, 2022

Record last verified: 2022-06

Locations

RU (5); US (71); UA (5); PL (5)