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

JRCT ID: jRCT2031240069

Registered date:09/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 22/05/2024
• Target sample size: 380
• Countries of recruitment: Argentina,Japan,Chile,Japan,Republic of Korea,Japan,Poland,Japan,United Kingdom,Japan,United States,Japan,Hungary,Japan,South Africa,Japan
• Study type: Interventional

Intervention(s)

Drug: Amlitelimab
Pharmaceutical form Injection Solution, Route of administration: subcutaneous (SC) injection
Drug: Placebo
Pharmaceutical form Injection Solution, Route of administration: SC injection

Study Arms:
- Experimental: Treatment group 1
SC Injection of Amlitelimab as per protocol
- Experimental: Treatment group 2
SC injection of Placebo as per protocol

Outcome(s)

Primary Outcome

1. Percentage of participants with treatment-emergent adverse events
[Time Frame: From baseline up to Week 156 (end of study [EOS] of LTS17510)]
Percentage of participants with treatment emergent Adverse Events.

Secondary Outcome

1. Percentage of participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs)
[Time Frame: From baseline up to Week 156 (EOS of LTS17510)]
2. Annualized rate of severe exacerbation events over treatment period from parent study baseline
[Time Frame: From baseline of the parent study up to Week 144 (end of treatment [EOT] of LTS17510)]
Severe exacerbation events are defined as: Worsening of asthma requiring the use of systemic corticosteroids for >= 3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
3. Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
[Time Frame: From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)]
Refer to the secondary outcome-2 for the definition of "severe exacerbation events".
4. Time to first exacerbation event from LTS17510 study baseline
[Time Frame: From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)]
5. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
[Time Frame: From baseline of the parent study up to Week 144 (EOT of LTS17510)]
Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for >= 3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
6. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline
[Time Frame: From baseline of the LTE17510 study up to Week 144 (EOT of LTS17510)]
Refer to the secondary outcome-5 for "severe asthma exacerbations".
7. Change from parent study baseline in pre-bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
[Time Frame: From baseline of parent study up to week 144 (EOT of LTS17510)]
8. Change from LTS17510 study baseline in pre-BD and post-BD FEV1 at each spirometry endpoint
[Time Frame: From baseline of LTS17510 study up to week 144 (EOT of LTS17510)]
9. Change from parent study baseline in pre-BD and post-BD peak expiratory flow (PEF) at each spirometry endpoint
[Time Frame: From baseline of parent study up to Week 144 (EOT of LTS17510)]
10. Change from LTS17510 study baseline in pre-BD and post-BD PEF at each spirometry endpoint
[Time Frame: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)]
11. Change from parent study baseline in pre-BD and post-BD forced vital capacity (FVC) at each spirometry endpoint
[Time Frame: From baseline of parent study up to Week 144 (EOT of LTS17510)]
12. Change from LTS17510 study Baseline in pre-BD and post-BD FVC at each spirometry endpoint
[Time Frame: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)]
13. Change from parent study baseline in pre-BD and post-BD forced expiratory flow (FEF) 25% to 75% at each spirometry endpoint
[Time Frame: From baseline of parent study up to Week 144 (EOT of LTS17510)]
14. Change from LTS17510 study baseline in pre-BD and post-BD FEF 25% to 75% at each spirometry endpoint
[Time Frame: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)]
15. Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
[Time Frame: From parent study baseline up to Week 144 (EOT of LTS17510)]
The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0 = no impairment, 6 = maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled).
16. Change from LTS17510 study baseline in ACQ-5, ACQ-6, and ACQ-7 scores
[Time Frame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)]
Refer to the secondary outcome-15 for "ACQ".
17. Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)
[Time Frame: From parent study baseline up to Week 144 (EOT of LTS17510)]
18. Change from LTS17510 study baseline in FeNO
[Time Frame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)]
19. Serum amlitelimab concentrations
[Time Frame: From baseline up to Week156 (EOS of LTS17510)]
20. Incidence of anti-amlitelimab antibody positive response
[Time Frame: From baseline up to Week 156 (EOS of LTS17510)]
21. Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
[Time Frame: From baseline up to Weeks 144 (EOT of LTS17510)]
The AQLQ (S) was designed as a self-administered participant reported outcome to measure the functional impairments that are most troublesome to adolescents and adults >= 12 years of age as a result of their asthma over the past two weeks. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol.
- Participants on background dose with medium-to-high doses of inhaled corticosteroid (ICS) therapy (>= 500 micro g of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 micro g/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], methylxanthines), with or without oral corticosteroid (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 micro g of fluticasone propionate daily or equivalent.
- 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.

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
- Chronic lung disease other than asthma.
- 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 investigational medicinal product discontinuation.
- Current smoker or active vaping of any products and/or marijuana smoking.
- Prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
- 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.
- 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.
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- 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.
- Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individual.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT06033833,2023-503385-24