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Trials |  |
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- || Lu AG09222 / Lundbeck
Enrollment open: A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine (clinicaltrials.gov) - Oct 1, 2024
P1, N=40, Recruiting, Sponsor: H. Lundbeck A/S
Not yet recruiting --> Recruiting
- || Lu AG09222 / Lundbeck
Clinical, Journal: A Monoclonal Antibody to PACAP for Migraine Prevention. (Pubmed Central) - Sep 4, 2024
P2
In a phase 2 trial, a single intravenous infusion of 750 mg of Lu AG09222 showed superiority over placebo in reducing migraine frequency over the subsequent 4 weeks. (Funded by H. Lundbeck; HOPE ClinicalTrials.gov number, NCT05133323.).
- || Lu AG09222 / Lundbeck
New P1 trial: A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine (clinicaltrials.gov) - Aug 29, 2024
P1, N=40, Not yet recruiting, Sponsor: H. Lundbeck A/S
- |||| Lu AG09222 / Lundbeck
Enrollment open: PROCEED: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - Apr 17, 2024
P2, N=498, Recruiting, Sponsor: H. Lundbeck A/S
(Funded by H. Lundbeck; HOPE ClinicalTrials.gov number, NCT05133323.). Not yet recruiting --> Recruiting
- ||||| Lu AG09222 / Lundbeck
New P2 trial: PROCEED: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - Mar 21, 2024
P2, N=498, Not yet recruiting, Sponsor: H. Lundbeck A/S
- || zelminemab (AMG 301) / Amgen, Novartis, Lu AG09222 / Lundbeck
Review, Journal: From CGRP to PACAP, VIP, and Beyond: Unraveling the Next Chapters in Migraine Treatment. (Pubmed Central) - Nov 28, 2023
In light of recent advances in PACAP research, we emphasize the potential of PACAP as a promising target for migraine treatment, highlighting the significance of exploring PACAP as a member of the antimigraine armamentarium, especially for patients who do not respond to or contraindicated to anti-CGRP therapies. By updating our knowledge of PACAP and its unique contribution to migraine pathophysiology, we can pave the way for reinforcing PACAP and other secretin peptides, including VIP, as a novel treatment option for migraines.
- |||| Lu AG09222 / Lundbeck
Trial completion: A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - Apr 6, 2023
P2, N=237, Completed, Sponsor: H. Lundbeck A/S
By updating our knowledge of PACAP and its unique contribution to migraine pathophysiology, we can pave the way for reinforcing PACAP and other secretin peptides, including VIP, as a novel treatment option for migraines. Active, not recruiting --> Completed
- ||| Lu AG09222 / Lundbeck
Enrollment closed: A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - Dec 8, 2022
P2, N=230, Active, not recruiting, Sponsor: H. Lundbeck A/S
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| Lu AG09222 / Lundbeck
Trial completion: A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants (clinicaltrials.gov) - Nov 10, 2022
P1, N=52, Completed, Sponsor: H. Lundbeck A/S
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || Lu AG09222 / Lundbeck
Trial completion: A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen (clinicaltrials.gov) - Oct 27, 2022
P1, N=30, Completed, Sponsor: H. Lundbeck A/S
Active, not recruiting --> Completed Recruiting --> Completed
- || Lu AG09222 / Lundbeck
Enrollment closed: A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants (clinicaltrials.gov) - Sep 10, 2022
P1, N=52, Active, not recruiting, Sponsor: H. Lundbeck A/S
Recruiting --> Completed Recruiting --> Active, not recruiting
- ||| Lu AG09222 / Lundbeck
New P1 trial: A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants (clinicaltrials.gov) - Mar 31, 2022
P1, N=52, Recruiting, Sponsor: H. Lundbeck A/S
- || Lu AG09222 / Lundbeck
Trial completion: A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects (clinicaltrials.gov) - Jan 19, 2022
P1, N=25, Completed, Sponsor: H. Lundbeck A/S
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||| Lu AG09222 / Lundbeck
New P2 trial: A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - Nov 23, 2021
P2, N=230, Recruiting, Sponsor: H. Lundbeck A/S
- || Lu AG09222 / Lundbeck
New P1 trial: A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen (clinicaltrials.gov) - Nov 18, 2021
P1, N=36, Recruiting, Sponsor: H. Lundbeck A/S
- || Lu AG09222 / Lundbeck
Enrollment closed: A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects (clinicaltrials.gov) - Nov 11, 2021
P1, N=25, Active, not recruiting, Sponsor: H. Lundbeck A/S
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || Lu AG09222 / Lundbeck
New P1 trial: A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects (clinicaltrials.gov) - Jul 26, 2021
P1, N=25, Recruiting, Sponsor: H. Lundbeck A/S
- || zelminemab (AMG 301) / Amgen, Novartis, Lu AG09222 / Lundbeck
Review, Journal: Targeting pituitary adenylate cyclase-activating polypeptide (PACAP) with monoclonal antibodies in migraine prevention: a brief review. (Pubmed Central) - Mar 5, 2021
Theoretically, if these antibodies block the activation of the trigeminovascular system, they will prevent the onset of migraine attacks. There are still knowledge gaps in the role of PACAP in migraine and the risk/benefit ratio of anti-PACAP antibodies must be carefully studied.
- | Lu AG09222 / Lundbeck
Phase classification: Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman (clinicaltrials.gov) - Sep 22, 2020
P1, N=96, Completed, Sponsor: H. Lundbeck A/S
There are still knowledge gaps in the role of PACAP in migraine and the risk/benefit ratio of anti-PACAP antibodies must be carefully studied. Phase classification: P=N/A --> P1
- ||| Lu AG09222 / Lundbeck
Trial completion: Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman (clinicaltrials.gov) - Aug 27, 2020
P=N/A, N=96, Completed, Sponsor: H. Lundbeck A/S
Phase classification: P=N/A --> P1 Recruiting --> Completed
- | Lu AG09222 / Lundbeck
Journal: Pharmacologic Characterization of ALD1910, a Potent Humanized Monoclonal Antibody against the Pituitary Adenylate Cyclase Activating Peptide. (Pubmed Central) - Dec 28, 2019
In vivo, this model demonstrates that the antagonistic activity of ALD1910 is dose-dependent, retaining efficacy at doses as low as 0.3 mg/kg. These results indicate that ALD1910 represents a potential therapeutic antibody to address PACAP-mediated migraine.
- ||| Lu AG09222 / Lundbeck
New trial: Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman (clinicaltrials.gov) - Dec 12, 2019
P=N/A, N=96, Recruiting, Sponsor: H. Lundbeck A/S