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Long-term evaluation of lunsekimig for adults with moderate-to-severe asthma

An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301

Phase 2 Interventional Sanofi · NCT06609239

This study is testing if a new asthma treatment called lunsekimig is safe and effective for adults with moderate-to-severe asthma over a long period of time.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment900 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsprednisone
Locations118 sites (Tucson, Arizona and 117 other locations)
Trial IDNCT06609239 on ClinicalTrials.gov

What this trial studies

This phase 2 open-label extension study aims to assess the long-term safety and efficacy of lunsekimig in adults who have moderate-to-severe asthma and have previously completed a parent study. Participants will receive lunsekimig treatment for up to 96 weeks, following a 48-week treatment period in the initial study. The study will monitor participants' responses and any adverse effects over a duration of up to 100 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate-to-severe asthma who have completed the prior 48-week treatment period of the parent study.

Not a fit: Patients who have not participated in the parent study or those with mild asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for adults with moderate-to-severe asthma, potentially improving their quality of life.

How similar studies have performed: Other studies evaluating similar long-term treatments for asthma have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
2. Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:

   * For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone
   * For Study ACT18301: LABA with or without LTRA
3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
4. Contraception for male and female participants

   For female participants:
   * must agree to use contraception/barrier
   * not pregnant or breast feeding
   * no eggs donation or cryopreserving eggs

   For male participants:
   * No sperm donation or cryopreserving sperm
5. Capable of giving signed informed consent

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

1. Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
2. Participant who was diagnosed with a new pulmonary disease which may impair lung function
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. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
6. Participants who are receiving prohibited concomitant medications
7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
8. Concurrent participation in any other clinical study, including non-interventional studies
9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

Tucson, Arizona and 117 other locations

+68 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Asthma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.