Long-term safety and efficacy evaluation of subcutaneous amlitelimab in adult participants with moderate to severe asthma who completed treatment period of previous amlitelimab asthma clinical study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

12 Mar 2024 → ongoing

Decision date (initial)

2023-09-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Research & Development

External identifiers

EU CT number

2023-503385-24-00

WHO UTN

U1111-1280-5321

ClinicalTrials.gov

NCT06033833

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Therapy, Others, Safety

To evaluate the safety and tolerability of long-term treatment with amlitelimab in participants with asthma

Secondary objectives 5

1. Additional characterization of safety and tolerability of long-term treatment with amlitelimab in participants with asthma
2. To evaluate long-term efficacy of amlitelimab in participants with asthma
3. To characterize the pharmacokinetic profile of amlitelimab in participants with asthma
4. To characterize immunogenicity of amlitelimab in participants with asthma
5. To evaluate the effects of amlitelimab on patient reported outcomes (PROs)

Conditions and MedDRA coding

Asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol.
2. Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated. Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
3. Contraception for male and female participants; For female participants: - incapable of becoming pregnant, - not pregnant or breast feeding, - not to donate or cryopreserve eggs for female participants For male participants: - No sperm donation or cryopreserving sperms

Exclusion criteria 10

1. Chronic lung disease other than asthma
2. Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator’s medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation.
3. Current smoker or active vaping of any products and/or marijuana smoking
4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
5. Participants who received prohibited concomitant medications and prohibited rescue medications
6. Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant.
7. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
8. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
9. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of participants with treatment-emergent adverse events

Secondary endpoints 21

1. Percentage of participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs)
2. Annualized rate of severe exacerbation events over treatment period from parent study baseline
3. Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
4. Time to first exacerbation event from LTS17510 study baseline
5. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
6. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline
7. Change from parent study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
8. Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
9. Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
10. Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
11. Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
12. Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
13. Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
14. Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
15. Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
16. Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
17. Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)
18. Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)
19. Serum amlitelimab concentrations
20. Incidence of anti- amlitelimab antibody positive response
21. Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 7

Locations

3 EU/EEA countries · 14 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

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

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

Documents 27 files

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

Application history

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