A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2025-07-11

Brief Summary

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The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ubrogepant with Lu AG09222

Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.

Group Type EXPERIMENTAL

Ubrogepant

Intervention Type DRUG

Tablet

Lu AG09222

Intervention Type DRUG

Solution for injection/infusion

Ubrogepant with Placebo

Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant.

Group Type PLACEBO_COMPARATOR

Ubrogepant

Intervention Type DRUG

Tablet

Placebo

Intervention Type DRUG

Solution for injection/infusion

Interventions

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Ubrogepant

Tablet

Intervention Type DRUG

Lu AG09222

Solution for injection/infusion

Intervention Type DRUG

Placebo

Solution for injection/infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The participant has a diagnosis of migraine as defined by ICHD-3 guidelines confirmed at the Screening Visit.
* The participant has a history of migraine onset ≥12 months prior to the Screening Visit.
* The participant has ≥2 migraine days and headache occurring on \<15 days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has a body mass index (BMI) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m\^2) at the Screening Visit.

Exclusion Criteria

* The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment.
* The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
* The participant has taken any investigational medicinal product (IMP) \<3 months or \<5 half-lives of that product, whichever is longer, prior to Visit 1.
* The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
* The participant has known or suspected hypersensitivity or intolerance to the IMP, auxiliary medicinal product (AxMP), or their excipients.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No