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Monoclonal Antibodies

Lu AG09222 for Migraine

Phase 1
Waitlist Available
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (predose) to day 84
Awards & highlights

Study Summary

This trial will study the effects of a single dose of Lu AG09222, given as an injection under the skin. Researchers will look at how the body absorbs and eliminates the drug, as well as any safety or tolerability effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (predose) to day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (predose) to day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent Elimination Half-Life (t½) of Lu AG09222
Apparent Total Clearance (CL/F)
Apparent Volume of Distribution (Vz/F)
+3 more
Secondary outcome measures
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)
Number of Participants With Specific Anti-Lu AG09222 Antibodies (Anti-Drug Antibodies [ADA])

Side effects data

From 2023 Phase 2 trial • 237 Patients • NCT05133323
4%
Fatigue
4%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lu AG09222 Low Dose
Placebo
Lu AG09222 High Dose

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lu AG09222 Low DoseExperimental Treatment1 Intervention
Participants will receive a single dose of Lu AG09222 by subcutaneous (SC) injection on Day 1.
Group II: Lu AG09222 High DoseExperimental Treatment1 Intervention
Participants will receive a single dose of Lu AG09222 by SC injection on Day 1.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo matching LU AG0922 by SC injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AG09222
2022
Completed Phase 2
~350

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,531 Total Patients Enrolled
12 Trials studying Migraine
4,734 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,288 Total Patients Enrolled
11 Trials studying Migraine
4,236 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
PAREXEL International
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants
2022. "A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05304910.
~17 spots leftby Apr 2025
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