Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Recruiting in Palo Alto (17 mi)

+364 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: * Systemic exposure * Anti-drug antibodies * Biomarkers

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Inclusion Criteria

- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.

Treatment Details

Interventions

Dupilumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: dupilumab treatmentExperimental Treatment1 Intervention

For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1\* Dose every 2 weeks added to current controller medications. For participants coming from other studies: dupilumab 1 \* Dose SC every 2 weeks added to current controller medications.