A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

Summary

This study is an open-label, multiple ascending dose investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CC312 in adult patients with relapsed or refractory autoimmune diseases.

Timeline

Start

2025-09-23

Primary completion

2027-09-29

Completion

2027-09-29

Publications

• Background Doria A, Amoura Z, Cervera R, Khamastha MA, Schneider M, Richter J, Guillemin F, Kobelt G, Maurel F, Garofano A, Perna A, Murray M, Schmitt C, Boucot I. Annual direct medical cost of active systemic lupus erythematosus in five European countries. Ann Rheum Dis. 2014 Jan;73(1):154-60. doi: 10.1136/annrheumdis-2012-202443. Epub 2012 Dec 21.
• Background Conrad N, Misra S, Verbakel JY, Verbeke G, Molenberghs G, Taylor PN, Mason J, Sattar N, McMurray JJV, McInnes IB, Khunti K, Cambridge G. Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK. Lancet. 2023 Jun 3;401(10391):1878-1890. doi: 10.1016/S0140-6736(23)00457-9. Epub 2023 May 5.
• Background Karagianni P, Tzioufas AG. Epigenetic perspectives on systemic autoimmune disease. J Autoimmun. 2019 Nov;104:102315. doi: 10.1016/j.jaut.2019.102315. Epub 2019 Aug 15.

Drugs

Indications