A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Summary

This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

Timeline

Start

2017-07-26

Primary completion

2021-12-24

Completion

2021-12-24

Publications

• Mattos WLLD, Khalil N, Spencer LG, Bonella F, Folz RJ, Rolf JD, Mogulkoc N, Lancaster LH, Jenkins RG, Lynch DA, Noble PW, Maher TM, Cottin V, Senger S, Horan GS, Greenberg S, Popmihajlov Z. Phase 2, Double-Blind, Placebo-controlled Trial of a c-Jun N-Terminal Kinase Inhibitor in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2024 Aug 15;210(4):435-443. doi: 10.1164/rccm.202310-1907OC.
• Popmihajlov Z, Sutherland DJ, Horan GS, Ghosh A, Lynch DA, Noble PW, Richeldi L, Reiss TF, Greenberg S. CC-90001, a c-Jun N-terminal kinase (JNK) inhibitor, in patients with pulmonary fibrosis: design of a phase 2, randomised, placebo-controlled trial. BMJ Open Respir Res. 2022 Jan;9(1):e001060. doi: 10.1136/bmjresp-2021-001060.
• Nagy MA, Hilgraf R, Mortensen DS, Elsner J, Norris S, Tikhe J, Yoon W, Paisner D, Delgado M, Erdman P, Haelewyn J, Khambatta G, Xu L, Romanow WJ, Condroski K, Bahmanyar S, McCarrick M, Benish B, Blease K, LeBrun L, Moghaddam MF, Apuy J, Canan SS, Bennett BL, Satoh Y. Discovery of the c-Jun N-Terminal Kinase Inhibitor CC-90001. J Med Chem. 2021 Dec 23;64(24):18193-18208. doi: 10.1021/acs.jmedchem.1c01716. Epub 2021 Dec 13.

Drugs

Indications