A Clinical Study of KLH-2109 in Patients With Endometriosis

NCT07015268 | Active Not Recruiting Phase 3

• 2 other identifiers: KLH1301Under registration
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic pain.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment

  NRS score for pelvic pain: The NRS score for pelvic pain is an integer scale of 0 to 10 in which the worst daily pain associated with endometriosis is scored as 0 for "no pain" and 10 for "the worst pain imaginable."

  12 weeks

Secondary Outcomes (9)

• Change from baseline in and actual values of the maximum NRS score for pelvic pain every 28 days

  Up to 24 weeks

• Change from baseline in and actual values of the maximum severity score for pelvic pain every 28 days

  Up to 24 weeks

• Change from baseline in and actual values of severity score for temporary pain at each evaluation time point

  Up to 24 weeks

• Change from baseline in and actual values of severity score of objective findings at each evaluation time point

  Up to 24 weeks

• Percent change from baseline in and actual values of ovarian chocolate cyst volume at each evaluation time point

  Up to 24 weeks

Study Arms (2)

KLH-2109 group

EXPERIMENTAL

Oral administration

Drug: KLH-2109

Leuprorelin group

ACTIVE COMPARATOR

Subcutaneous administration

Drug: Leuprorelin acetate

Interventions

KLH-2109 DRUG

\- KLH-2109 tablet: Oral administration \- Leuprorelin acetate placebo: Subcutaneous administration

KLH-2109 group

Leuprorelin acetate DRUG

\- KLH-2109 placebo tablet: Oral administration \- Leuprorelin acetate: Subcutaneous administration

Leuprorelin group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of endometriosis by laparotomy or laparoscopy within 5 years before the start of the screening period;
• Ovarian chocolate cyst confirmed by MRI performed within 1 year before the start of the screening period or ultrasonography (transvaginal, transabdominal, or transrectal) carried out at the start of the screening period; or
• Any of induration of the pouch of Douglas, limitation of uterine mobility, and pelvic tenderness based on the result of pelvic/rectal examination at the start of the screening period and a diagnosis of clinical endometriosis

You may not qualify if:

• Patients with undiagnosed abnormal genital bleeding
• Patients with abnormal uterine bleeding or anovulatory bleeding judged to be severe by the principal investigator or subinvestigator
• Patients with concomitant chronic abdominal pain not attributable to endometriosis (such as irritable bowel syndrome \[IBS\] and interstitial cystitis)
• Patients with concomitant pelvic inflammatory disease or a history of pelvic inflammatory disease within 8 weeks before obtaining informed consent

Sponsors & Collaborators

• Kissei Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Research Site

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Endometriosis

Interventions

linzagolix; Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Yoshitaka Shimizu

  Kissei Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

JP (1)