Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Intervention1: Lunsekimig: Dose formulation: Solution for injection in vial
Unit dose strength(s): 165mg/1.1 mL
Intervention description: lunsekimig 300 mg SC injection Q4W.
Route of Administration: S
Sponsors
Sanofi Healthcare India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants who completed the 48-week treatment period of DRI16762 study, including EOT visit, as per protocol. 2. Participants with stable background therapy of moderate to high ICS therapy (>=500 µg/day to 2000 µg/day fluticasone propionate or equivalent ICS dosage daily) (2) in combination with at least 1 but no more than 2 additional controller medications (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone as maintained during the parent study in which they have participated. 3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures. Weight Not applicable. Sex, contraceptive/barrier method and pregnancy testing requirements or breastfeeding- All 4. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants Male participants with partners of childbearing potential are eligible to participate if they agree to the following during the study intervention period and during 8 weeks following the last administration of study intervention: - Refrain from donating or cryopreserving sperm. PLUS, either- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR - Must agree to use contraception/barrier as detailed below. A male condom and an additional highly effective contraceptive method as described in Appendix 4: Section 10.4 (Contraceptive and barrier guidance) when having sexual intercourse with a WOCBP who is not currently pregnant. b- Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies- Is a WONCBP as defined in Section 10.4.1 (Definitions). OR - Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of less than 1percentper year) preferably with low user dependency, as described in Appendix 4-Section 10.4 (Contraceptive and barrier guidance). Contraception and barrier guidance should be followed during the study intervention period (to be effective before starting the intervention) and during 8 weeks following the last IMP administration. The WOCBP should also agree not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period. A WOCBP must have a negative urine pregnancy test (serum as required by local regulations) at baseline, to be performed before the first administration of lunsekimig (see Section 8.3.5). 5.Informed Consent Capable of giving signed informed consent as described in Appendix 1:Section 10.1 (Regulatory, ethical, and study oversite consideration) which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participants LAR.
Exclusion criteria
Exclusion criteria: Medical conditions 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 Investigatorâ??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 andor 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- a. Systemic steroids (except systemic steroids to treat asthma exacerbations for maintenance treatment of asthma within allowed doses initiated before participation in the study, and in short courses (less than 7 days) in the treatment of other conditions other than asthma). b. Systemic immunosuppressant (eg, methotrexate, any anti-TNF mAbs, B and/or T cell targeted immunosuppressive therapies). c. IV immunoglobulin therapy d. Anti-IgE therapy or any other biologic therapy. e. Live attenuated vaccines. Note- The participant who receives live-attenuated vaccine at the EOT of DRI16762, will wait for 24 weeks before entering LTS17231 study. During the study, if the participant receives live-attenuated vaccine, heorshe can reenter the study after 24 weeks. f. Beta-adrenergic receptor blockers (except for a selective beta-1 adrenergic receptor blocker used with stable dose). g. Asthma relievers other than SABA and low-dose ICSorformoterol- their use is not recommended during the study period. In case of use in exceptional circumstances eg, prescribed by a physician not participating in the study or in case SAMA was used as reliever medication in the parent study), their use will be documented in the participants file and reported in the eCRF. h. Initiation of immunotherapy i. Herbal medications for asthma or wheeze. j. Other investigational drugs 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 (in conjunction with Section 1.61 of the (ICH-GCP) Ordinance E6). 11. Any country-related specific regulation that would prevent the participant from entering the study - see Section 10.9(Country-specific requirements)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of asthma exacerbation events at Weeks 48 and 96 from LTE study baseline.Timepoint: 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate long-term efficacy of lunsekimig in adult participants with moderate-to-severe asthmaTimepoint: asthma exacerbation events at Week 48 and Week 96 from long-term extension (LTE) study baseline | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Chile, China, Czech Republic, Hungary, India, Israel, Japan, Mexico, Netherlands, Poland, Republic of Korea, Romania, South Africa, Spain, Turkey, United States of America
Contacts
Public ContactLaxman Deshmukh
Sanofi Healthcare India Private Limited
Outcome results
None listed