Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

Summary

Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Timeline

Start

2018-03-05

Primary completion

2020-09-25

Completion

2020-09-25

Outcome

Missed primary endpoint

paper the primary endpoint was not met PMID 35364018 ↗

registry Cumulative Odds Ratio 1.28 (95% CI 0.69 to 2.35); Proportional odds model NCT03406078 ↗

release “today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose” amgen.com ↗

release “SOURCE Phase 3 trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose” amgen.com ↗

Publications

• Menzies-Gow A, Wechsler ME, Brightling CE, Korn S, Corren J, Israel E, Chupp G, Bednarczyk A, Ponnarambil S, Caveney S, Almqvist G, Golabek M, Simonsson L, Lawson K, Bowen K, Colice G; DESTINATION study investigators. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study. Lancet Respir Med. 2023 May;11(5):425-438. doi: 10.1016/S2213-2600(22)00492-1. Epub 2023 Jan 23.
• Wechsler ME, Menzies-Gow A, Brightling CE, Kuna P, Korn S, Welte T, Griffiths JM, Salapa K, Hellqvist A, Almqvist G, Lal H, Kaur P, Skarby T, Colice G; SOURCE study group. Evaluation of the oral corticosteroid-sparing effect of tezepelumab in adults with oral corticosteroid-dependent asthma (SOURCE): a randomised, placebo-controlled, phase 3 study. Lancet Respir Med. 2022 Jul;10(7):650-660. doi: 10.1016/S2213-2600(21)00537-3. Epub 2022 Mar 29.
• Wechsler ME, Colice G, Griffiths JM, Almqvist G, Skarby T, Piechowiak T, Kaur P, Bowen K, Hellqvist A, Mo M, Garcia Gil E. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res. 2020 Oct 13;21(1):264. doi: 10.1186/s12931-020-01503-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tezepelumab	Monoclonal antibody	210 mg	—

Indications