| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02194699 | A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma | PHASE3 | COMPLETED | 856 | — | — | Oct 30, 2014 | Sep 21, 2017 | May 15, 2018 | 234 | United States, Canada +11 |
Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.
| Arm | Type | Description |
|---|---|---|
| Tralokinumab | EXPERIMENTAL | Tralokinumab subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Placebo subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Experimental: Tralokinumab | BIOLOGICAL | Tralokinumab subcutaneous injection |
| Placebo | OTHER | Placebo subcutaneous injection |
Inclusion Criteria: 1. Age 12 -75 2. Documented physician-diagnosed asthma. 3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA 4. Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12...