Linzagolix for Endometriosis

No longer recruiting at 78 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: ObsEva SA

Must be taking: Add-back therapy

Must not be taking: GnRH agonists

Disqualifiers: Pregnancy, Osteoporosis, Chronic pelvic pain, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new medication, linzagolix, for treating pain caused by endometriosis, a condition where tissue similar to the uterine lining grows outside the uterus, causing pain. The study compares linzagolix alone at a low dose, or at a higher dose with add-back hormone replacement therapy, against a placebo (a pill with no active drug) to determine the most effective treatment. Women diagnosed with endometriosis through surgery in the past ten years and experiencing moderate to severe pain may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic pain medication for conditions other than endometriosis, it might interfere with the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that linzagolix is generally well-tolerated for treating pain caused by endometriosis. One study found that taking 200 mg of linzagolix with add-back hormone therapy (a mix of estradiol and norethisterone acetate) helped reduce this pain. Most patients responded well to this combination, experiencing only minor changes in bone strength.

For those taking a lower dose of 75 mg of linzagolix, research also shows it is well-tolerated. Although detailed long-term safety data beyond one year is not available, current information suggests it is safe for shorter-term use.

Overall, both doses of linzagolix, whether used with or without add-back therapy, have demonstrated promising safety based on past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Linzagolix is unique because it offers a new way to manage endometriosis-associated pain by using a selective GnRH receptor antagonist. Unlike traditional treatments like hormonal contraceptives or GnRH agonists, which can have significant side effects or require injections, Linzagolix is taken orally. Researchers are excited about its potential to effectively reduce pain with fewer side effects and improve quality of life. The additional option of a combined treatment with add-back therapy (estrogen and norethindrone acetate) aims to maintain bone health and manage other hormonal symptoms, setting it apart from existing therapies.

What evidence suggests that this trial's treatments could be effective for endometriosis-associated pain?

Studies have shown that linzagolix effectively treats pain caused by endometriosis. In this trial, participants may receive either a 200 mg dose of linzagolix with add-back hormone replacement therapy or a 75 mg dose of linzagolix. Specifically, the 200 mg dose, when combined with additional supportive treatment, significantly reduced both menstrual and non-menstrual pelvic pain after three months. Research indicates that the 75 mg dose also reduces pain, with 44% of patients experiencing relief from painful periods compared to 23.5% who took a placebo. Both doses of linzagolix were well-tolerated over several months, improving the quality of life for many women. These findings suggest linzagolix could be a promising option for managing endometriosis pain. ^{2 3 4 5 6}

Who Is on the Research Team?

Lecomte

Principal Investigator

ObsEva SA

Are You a Good Fit for This Trial?

Inclusion Criteria

The study found that moderate to severe endometriosis-associated pain during the screening period was common.

Having regular menstrual cycles means that a woman's period comes every 28 days or so.

A person's BMI was ≥ 18 kg/m2 at the screening visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive linzagolix or placebo orally once daily for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Extension

Eligible participants may enter a separate extension study for 6 additional months of active treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Add-back hormone replacement therapy
• Linzagolix

How Is the Trial Designed?

Group I: Linzagolix 75 mg Experimental Treatment 3 Interventions

Group II: Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Experimental Treatment 3 Interventions

Group III: Placebo Placebo Group 3 Interventions

Who Is Running the Clinical Trial?

ObsEva SA

Lead Sponsor

Trials

14

Recruited

4,400+

Kissei Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

62

Recruited

8,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38648863/

Linzagolix therapy versus a placebo in patients with ... - PubMed Combining 200 mg linzagolix with ABT was found to significantly reduce dysmenorrhea and non-menstrual pelvic pain at 3 months of therapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03986944

NCT03986944 | A Phase 3 Study to Confirm the Efficacy ... The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9922511/

Profile of Linzagolix in the Management of Endometriosis ... 18 Linzagolix therapy displayed clinical benefits over 52 weeks of continuous daily administration, providing relief from endometriosis- ...

4. fertstert.org fertstert.org/article/S0015-0282(20)32218-4/fulltext

LINZAGOLIX MAY ADDRESS THE LONG-TERM ... LINZAGOLIX MAY ADDRESS THE LONG-TERM TREATMENT NEEDS OF WOMEN WITH UTERINE FIBROIDS (UF) WHO HAVE CONTRAINDICATIONS TO HORMONAL ADD-BACK THERAPY (ABT): RESULTS ...

5. academic.oup.com academic.oup.com/humrep/article/39/6/1208/7656387

Linzagolix therapy versus a placebo in patients with ... Combining 200 mg linzagolix with ABT was found to significantly reduce dysmenorrhea and non-menstrual pelvic pain at 3 months of therapy.

6. ema.europa.eu ema.europa.eu/en/documents/rmp/yselty-epar-risk-management-plan_en.pdf

EU Risk Management Plan (RMP) for YSELTY (linzagolix) 100 mg or, if needed, 200 mg once daily with concomitant hormonal add-back therapy (ABT, E2 1 mg and norethisterone acetate (NETA) 0.5 mg ...