A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Ubrogepant; Drug: Lu AG09222; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research
  • Texas
    • Austin, Texas, United States, 78731
      • Future Search Trials
    • Seabrook, Texas, United States, 77586
      • Elevate Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ubrogepant with Lu AG09222; Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.	Drug: Ubrogepant; Tablet; Drug: Lu AG09222; Solution for injection/infusion
Placebo Comparator: Ubrogepant with Placebo; Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant.	Drug: Ubrogepant; Tablet; Drug: Placebo; Solution for injection/infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)	Up to 92 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity	Predose on Day 1 to Day 12
Cmax: maximum observed plasma concentration of ubrogepant	Predose on Day 1 to Day 12
tmax: nominal time corresponding to the occurrence of Cmax	Predose on Day 1 to Day 12
t½: apparent elimination half-life of ubrogepant	Predose on Day 1 to Day 12
Oral Clearance (CL/F) of ubrogepant	Predose on Day 1 to Day 12
Apparent volume of distribution (VZ/F) of ubrogepant	Predose on Day 1 to Day 12
Number of participants with anti-drug antibodies for Lu AG09222	Up to 92 Days

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; ubrogepant
• Other Study ID Numbers: 20527A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No