Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Lunsekimig — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• Placebo — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous

Study Details

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

Key Dates

Start date

Oct 16, 2023

Status verified

Mar 2026

Primary completion

Feb 23, 2026

Completion

Mar 11, 2026

Study Design

Enrollment

685 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lunsekimig Dose1 interval 1
  Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1
• Experimental: Lunsekimig Dose 1 interval 2
  Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2
• Experimental: Lunsekimig Dose 2 interval 1
  Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1
• Experimental: Lunsekimig Dose 2 interval 2
  Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2
• Placebo Comparator: Placebo
  Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2

Primary Outcome Measure

Annualized rate of asthma exacerbation events [ Time Frame: From baseline to week 48 ]

Locations (48)

Find similar trials in Scottsdale, AZ

Related Studies

• Role of Genetic Factors in the Development of Lung Disease
  Recruiting · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland
• Personalized Environment and Genes Study
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Chapel Hill, North Carolina
• Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
  Recruiting · Gelb, Arthur F., M.D. · Lakewood, California
• Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
  PHASE1 · Recruiting · Benjamin Medoff · Boston, Massachusetts