A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Lundbeck

Status and phase: Enrolling; Phase 1

Conditions: Migraine

Treatments: Drug: Ubrogepant; Drug: Placebo; Drug: Lu AG09222

Study type: Interventional

Funder types: Industry

Identifiers

NCT06578585

20527A

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Ubrogepant with Lu AG09222

Experimental group

Description:

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

Treatment:

Drug: Lu AG09222

Drug: Ubrogepant

Ubrogepant with Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Ubrogepant