Enrolling by invitation NCT06609239

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma

Phase II Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Lunsekimig.
Who it may be relevant to: Registry conditions: Asthma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Canada, Chile +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig. The study duration will be up to 148 weeks with a treatment duration being up to 144 weeks.

Interventions

Drug Lunsekimig
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Primary outcome measures

Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) [Time frame: From study baseline to week 148]

Secondary outcome measures (7)

Annualized rate of asthma exacerbation events [Time frame: From study baseline to weeks 48, 96 and 144]
Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) [Time frame: From parent study baseline to weeks 48, 96 and 144]
Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score [Time frame: From parent study baseline to weeks 48, 96 and 144]
Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score [Time frame: From parent study baseline to weeks 48, 96 and 144]
Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores [Time frame: From parent study baseline to weeks 48, 96 and 144]
Serum lunsekimig concentrations [Time frame: From study baseline to week 144]
Incidence and titer of anti-drug antibodies (ADA) against lunsekimig [Time frame: From study baseline to week 144]

Eligibility criteria

Inclusion criteria

Participants who completed the treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
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
Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And:

For female participants:

incapable of becoming pregnant, or
not pregnant or breast feeding
no eggs donation or cryopreserving eggs

For male participants:

\-- No sperm donation or cryopreserving sperm

\- Capable of giving signed informed consent

Exclusion criteria

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

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
Participant who was diagnosed with a new pulmonary disease which may impair lung function
Current smoker or active vaping of any products and/or marijuana smoking
Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
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
Participants who are receiving prohibited concomitant medications
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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 29 centers

Chandler Clinical Research Trials- Site Number : 8400075 — Chandler
Tucson Clinical Research Institute- Site Number : 8400085 — Tucson
Allianz Research Institute - Aurora- Site Number : 8400026 — Aurora
Western States Clinical Research- Site Number : 8400014 — Wheat Ridge
Helix Biomedics- Site Number : 8400114 — Boynton Beach
Beautiful Minds Clinical Research Center- Site Number : 8400049 — Cutler Bay
Qway Research - Hialeah- Site Number : 8400015 — Hialeah
Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048 — Miami
… and 21 more centers

China · 19 centers

Investigational Site Number : 1560011 — Beijing
Investigational Site Number : 1560010 — Changchun
Investigational Site Number : 1560017 — Changsha
Investigational Site Number : 1560053 — Guangzhou
Investigational Site Number : 1560009 — Guangzhou
Investigational Site Number : 1560001 — Guangzhou
Investigational Site Number : 1560006 — Hefei
Investigational Site Number : 1560014 — Hohhot
… and 11 more centers

Argentina · 13 centers

Investigational Site Number : 0320007 — Berazategui
Investigational Site Number : 0320003 — La Plata
Investigational Site Number : 0320002 — Rosario
Investigational Site Number : 0320006 — Rosario
Investigational Site Number : 0320008 — San Miguel de Tucumán
Investigational Site Number : 0320005 — Buenos Aires
Investigational Site Number : 0320012 — Buenos Aires
Investigational Site Number : 0320004 — Buenos Aires
… and 5 more centers

Brazil · 8 centers

Associacao Proar- Site Number : 0760003 — Salvador
Universidade Federal de Goias- Site Number : 0760007 — Goiânia
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002 — Curitiba
Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009 — Recife
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001 — Porto Alegre
Hospital Dia do Pulmão- Site Number : 0760005 — Blumenau
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006 — Rio de Janeiro
Incor - Instituto do Coracao- Site Number : 0760011 — São Paulo

Chile · 8 centers

Investigational Site Number : 1520013 — Concepción
Investigational Site Number : 1520001 — Talca
Investigational Site Number : 1520006 — Santiago
Investigational Site Number : 1520005 — Santiago
Investigational Site Number : 1520004 — Santiago
Investigational Site Number : 1520002 — Santiago
Investigational Site Number : 1520008 — Quillota
Investigational Site Number : 1520011 — Viña del Mar

Israel · 8 centers