Phase 3
Completed N=140
Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma
Source: ClinicalTrials.gov NCT02281357 ↗Enrolled (actual)
140
Serious AEs
17.9%
Results posted
May 2018
Primary outcomePrimary: Percent Change From Baseline in the Final Daily, Average, OCS Dose at Week 40 While Not Losing Asthma Control. — -37.62; -29.85 Percent change from baseline — p=0.271
◆ Published Evidence
Established
23citations · ~3 / year
Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program.
Summary
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent Asthma.
Linked Publications
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Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in the Final Daily, Average, OCS Dose at Week 40 While Not Losing Asthma Control. |
-37.62; -29.85 | 0.271 |
| SECONDARY The Number of Patients With Final Daily Average OCS Dose ≤5 mg at Week 40. |
32; 28 | 0.442 |
| SECONDARY The Number of Patients With ≥50% Reduction in Final Average Daily OCS Dose at Week 40. |
31; 26 | 0.356 |
| SECONDARY Annual Asthma Exacerbation Rate (AAER) up to Week 40. |
1.84; 2.31 | 0.186 |
Eligibility Criteria
Inclusion Criteria
- 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 and a LABA. 4) Subjects must have received OCS for the treatment of asthma for 6 months prior to Visit 1 and on a stable OCS dose between ≥7.5 to ≤30mg daily or daily equivalent for at least one month prior to enrolment (Visit 1) . 5) Pre-BD FEV1 value <80% (<90% for patients 12-17 yrs of age) of their PNV. 6) Post-BD reversibility of ≥12% in FEV1.
Exclusion Criteria
- Clinically important pulmonary disease other than asthma. 2) History of anaphylaxis following any biologic therapy. 3) Hepatitis B, C or HIV. 4) Pregnant or breastfeeding. 5) History of cancer. 6) Current tobacco smoking or a history of tobacco smoking for ≥10 pack-years. 7) Previous receipt of tralokinumab.
Data sourced from ClinicalTrials.gov (NCT02281357) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.