330 Participants NeededMy employer runs this trial

EVO756 for Migraine

Recruiting at 14 trial locations
NB
Overseen ByNichole Baio
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, EVO756, to determine its effectiveness in reducing migraines. Researchers aim to assess the safety and efficacy of EVO756 compared to a placebo (a pill with no active drug). Participants will receive either one of two doses of EVO756 or a placebo daily. The trial seeks adults who experience migraines, with or without aura, and have not found success with other migraine prevention treatments. Participants should not currently use any preventive migraine therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that certain medications may exclude you from participating. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that EVO756 is likely to be safe for humans?

Research has shown that EVO756 underwent safety testing in earlier studies. The results indicated that participants tolerated EVO756 well at various doses. Importantly, these studies found no new safety issues, meaning most participants did not experience serious side effects. Although the treatment remains under investigation, current findings suggest that EVO756 does not pose major safety concerns for users.12345

Why do researchers think this study treatment might be promising for migraine?

Most treatments for migraines, like triptans and beta-blockers, work by constricting blood vessels or altering neurotransmitter levels. But EVO756 works differently, targeting specific pathways involved in the pain mechanism of migraines. Researchers are excited about EVO756 because it offers a novel approach with the potential for fewer side effects and improved efficacy. Unlike existing options, which are often injected or come with dietary restrictions, EVO756 is an orally administered medication, making it convenient for daily use.

What evidence suggests that EVO756 might be an effective treatment for migraine?

Research suggests that EVO756 could help treat migraines. In earlier studies, some patients experienced fewer migraine days each month, with reductions of 50% or even 75%. EVO756 targets a specific receptor linked to migraine symptoms, preventing certain cells from releasing substances that worsen migraines. Although researchers are still studying EVO756, early results in similar conditions like chronic hives show it effectively reaches its target in the body. This offers hope for its potential to help with migraines.13678

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to under 65 who have migraines (with or without aura) and haven't had success with previous preventive migraine treatments. Participants should not currently be using any migraine prevention medications.

Inclusion Criteria

Has a doctor told you that you have migraines, and have you had them for at least 1 year?
In a typical month, do you get at least 6 days with a migraine?
Have you tried a treatment to prevent migraines (e.g., a daily pill, a monthly shot, or Botox) that didn't work well enough?
See 2 more

Exclusion Criteria

Besides migraines, do you have other headache conditions (such as cluster headaches) or a long-term pain condition (such as fibromyalgia or facial nerve pain)?
Do you use opioid pain medicines, or barbiturate medicines like Fioricet or Fiorinal, on more than 2 days in a typical month?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EVO756 or placebo daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EVO756

Trial Overview

The study compares two different doses of a new drug called EVO756 to a placebo, aiming to see how well EVO756 works and how safe it is for treating migraines in adults.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 2Experimental Treatment1 Intervention
Group II: Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Evommune, Inc.

Lead Sponsor

Trials
5
Recruited
380+

Citations

Evommune Initiates Phase 2b Clinical Trial of MRGPRX2 ...

The Phase 2b trial is a global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating EVO756 in adults with refractory ...

Evommune begins Phase IIb trial of EVO756 for migraine

Additional secondary outcomes will include the proportion of patients achieving at least 50% and 75% reductions in monthly migraine days, ...

EVO756 / Evommune, Maruho

Approximately 330 patients will be randomized across two active dose arms and placebo for 12 weeks of treatment....Top-line data expected in 2027."

EVO-756 - Drug Targets, Indications, Patents

... Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults ... “EVO756 previously delivered positive Phase 2 data in chronic ...

Evommune's EVO756 Misses Primary End Point in Phase ...

“EVO756 previously delivered positive Phase 2 data in chronic inducible urticaria and showed clear target engagement in the Phase 1 trial, ...

EVO756 / Evommune, Maruho

Approximately 330 patients will be randomized across two active dose arms and placebo for 12 weeks of treatment....Top-line data expected in 2027."

MRGPRX2 as a novel therapeutic target in headache

A randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of EVO756 in adults with atopic dermatitis.

Evommune Initiates Phase 2b Trial of its Oral MRGPRX2 ...

... safety of EVO756 in adult patients with moderate to severe AD. Patients will be randomized to receive EVO756 or matching placebo for 12 weeks.