A dose-finding trial with LU AG90222 in adults with migraine who have not been helped by prior preventative treatments.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

H. Lundbeck A/S

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

14 Aug 2024 → 17 Mar 2026

Decision date (initial)

2024-07-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

H. Lundbeck A/S

External identifiers

EU CT number

2023-508821-28-00

ClinicalTrials.gov

NCT06323928

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Safety

To evaluate the efficacy of Lu AG09222 for the prevention of migraine

Secondary objectives 4

1. To evaluate the dose response relationship for efficacy of Lu AG09222 for the prevention of migraine
2. To evaluate the efficacy of Lu AG09222 for the prevention of migraine
3. To evaluate the safety and tolerability of Lu AG09222
4. To evaluate the immunogenicity of Lu AG09222

Conditions and MedDRA coding

Migraine

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-003483-PIP01-23

Plan to share IPD

Yes

IPD plan description

Lundbeck is committed to share the data from this clinical trial when the product is approved in Europe and/or the United States. Please visit www.lundbeck.com for more information about our clinical data sharing policy and processes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. The participant has a diagnosis of migraine as defined by ICHD-3 guidelines (section 1.1 Migraine without Aura, or 1.2.1 Migraine with typical Aura, or 1.3 Chronic Migraine) confirmed at the Screening Visit.
2. The participant has a history of migraine onset ≥12 months prior to the Screening Visit.
3. The participant has a migraine onset at ≤50 years of age.
4. The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
5. The participant fulfils the following criteria for EM or CM in prospectively collected information in the eDiary during the first 28 days of the Screening Period: o For participants with EM: migraine occurring on ≥4 days and headache occurring on <15 days o For participants with CM: migraine occurring on ≥8 days and headache occurring on ≥15 days and ≤26 days
6. The participant has demonstrated compliance with the eDiary by entry of data for ≥24 of the 28 days following the Screening Visit.
7. The participant has had treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications out of the following, of which at least one must be due to inadequate efficacy: o propranolol/metoprolol o topiramate o amitriptyline o flunarizine/lomerizine o candesartan o valproate/divalproex o botulinum toxin (if documented that botulinum toxin was taken for CM)
8. The participant is aged ≥18 and ≤65 years at the Screening Visit

Exclusion criteria 4

1. The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
2. The participant has a diagnosis of acute or active temporomandibular disorder.
3. The participant has a history or diagnosis of chronic tension-type headache, cluster headache, headache attributed to trauma or injury to the head and/or neck, paroxysmal hemicrania, short lasting unilateral neuralgiform headache attacks, hemicrania continua, primary thunderclap headache, primary stabbing headache, nummular headache, new daily persistent headache, hypnic headache, trigeminal neuralgia, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness) or aura lasting >60 minutes.
4. The following concomitant medications/substances are disallowed or allowed with restrictions (the list is not comprehensive): Disallowed: any investigational products within 30 days or 5 half-lives (whichever is longer) before the Screening Visit; preventive migraine treatments; anti-CGRP treatment; CNS- or migraine-related devices (neuromodulation, neurostimulation) or injectable therapies (such as trigger-point injections, extracranial nerve blocks, or facet joint injections); botulinum toxin; or monoamine oxidase inhibitors, ketamine, methysergide, methylergonovine, or nimesulide; immunosuppressants (for example, systemic steroids). Allowed with restriction: acute treatment of migraine (prescription or OTC medication), amphetamines, anti-impotence agents; barbiturates (including Fiorinal, Fioricet, or any other combination containing butalbital); opiates (including single-ingredient or combination medications containing opiates, opioids, tramadol, or tapentadol); cannabinoids; benzodiazepines; inhalation steroids; vaccinations; nonpharmacological interventions and therapies; traditional Chinese medicines.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in Monthly Migraine Diary (Weeks 1-12) (efficacy)

Secondary endpoints 9

1. Change from baseline in Monthly Migraine Diary (Weeks 1-12) (dose response)
2. 50% Monthly Migraine Diary response: ≥50% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12)
3. 75% Monthly Migraine Diary response: ≥75% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12)
4. Change from baseline in Monthly Headache Days (Weeks 1-12)
5. TEAEs
6. Changes from baseline in clinical safety laboratory test values, vital signs, weight, and ECG parameter values
7. PCS clinical safety laboratory test values, vital signs, weight changes, and ECG parameter values
8. Suicidal ideation and behaviour based on the C-SSRS
9. Development of ADAs, characterization of ADAs, and impact of ADA on PK, efficacy, and safety

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

H. Lundbeck A/S

Sponsor organisation

H. Lundbeck A/S

Address

Ottiliavej 9

City

Valby

Postcode

2500

Country

Denmark

Scientific contact point

Organisation

H. Lundbeck A/S

Contact name

Lundbeck Clinical Trials

Public contact point

Organisation

H. Lundbeck A/S

Contact name

Lundbeck Clinical Trials

Third parties 6

Locations

11 EU/EEA countries · 77 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 220 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

14 submissions — initial application plus substantial / non-substantial modifications