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Completed

NCT Number: NCT06578585

A Trial Investigating Lu AG09222 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Neuroscience Solutions, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ubrogepant

Drug

Tablet

Lu AG09222

Drug

Solution for injection/infusion

Placebo

Drug

Solution for injection/infusion

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 92 Days

Secondary outcomes

  1. AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity

    Time frame: Predose on Day 1 to Day 12

  2. Cmax: maximum observed plasma concentration of ubrogepant

    Time frame: Predose on Day 1 to Day 12

  3. tmax: nominal time corresponding to the occurrence of Cmax

    Time frame: Predose on Day 1 to Day 12

  4. t½: apparent elimination half-life of ubrogepant

    Time frame: Predose on Day 1 to Day 12

  5. Oral Clearance (CL/F) of ubrogepant

    Time frame: Predose on Day 1 to Day 12

  6. Apparent volume of distribution (VZ/F) of ubrogepant

    Time frame: Predose on Day 1 to Day 12

  7. Number of participants with anti-drug antibodies for Lu AG09222

    Time frame: Up to 92 Days

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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