Clinical trial NCT06578585: A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
Official title: Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to 92 Days
Secondary outcomes:
measure: AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity
timeFrame: Predose on Day 1 to Day 12
measure: Cmax: maximum observed plasma concentration of ubrogepant
timeFrame: Predose on Day 1 to Day 12
measure: tmax: nominal time corresponding to the occurrence of Cmax
timeFrame: Predose on Day 1 to Day 12
measure: t½: apparent elimination half-life of ubrogepant
timeFrame: Predose on Day 1 to Day 12
measure: Oral Clearance (CL/F) of ubrogepant
timeFrame: Predose on Day 1 to Day 12
measure: Apparent volume of distribution (VZ/F) of ubrogepant
timeFrame: Predose on Day 1 to Day 12
measure: Number of participants with anti-drug antibodies for Lu AG09222
timeFrame: Up to 92 Days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research
state: Georgia
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Seabrook
country: United States
facility: Elevate Clinical Research
state: Texas
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: