Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab SAR231893 (REGN668) — DRUG
  Pharmaceutical form: prefilled syringes Route of administration: subcutaneous

Study Details

Primary Objective: To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).

Key Dates

Start date

Aug 30, 2018

Status verified

Feb 2023

Primary completion

Feb 18, 2022

Completion

Feb 18, 2022

Study Design

Enrollment

393 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Participants received subcutaneous (SC) dose of dupilumab 300 milligrams (mg) every 2 weeks (q2w) from Week 0 up to Week 132. Participants who discontinued treatment for greater than or equal to (\>=) 6 weeks after study LTS12551 (NCT02134028), received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose inhaled corticosteroid (ICS) as maintained in study LTS12551 in combination with controllers (and/or oral corticosteroid \[OCS\] for those participants from the original parent study EFC13691 \[NCT02528214\]). Salbutamol/albuterol hydrofluoroalkane pressurized metered dose inhalers (MDI) or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.

Primary Outcome Measure

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks) ]

Locations (35)

Find similar trials in Gilbert, AZ

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