A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
- Registration Number
- NCT06578585
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ubrogepant with Lu AG09222 Lu AG09222 Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant. Ubrogepant with Placebo Ubrogepant Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant. Ubrogepant with Placebo Placebo Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant. Ubrogepant with Lu AG09222 Ubrogepant Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) Up to 92 Days
- Secondary Outcome Measures
Name Time Method t½: apparent elimination half-life of ubrogepant Predose on Day 1 to Day 12 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 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
Trial Locations
- Locations (4)
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
NeuroTrials Research
🇺🇸Atlanta, Georgia, United States
Future Search Trials
🇺🇸Austin, Texas, United States
Elevate Clinical Research
🇺🇸Seabrook, Texas, United States