drugset / Trial / NCT01986933
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy
Timeline
- Start
- 2013-11
- Primary completion
- 2015-04
- Completion
- 2016-06
Outcome
Met primary endpoint
registry p = 0.0027; Mean Difference (Final Values) -21.39 (95% CI -35.25 to -7.53) NCT01986933 ↗
Publications
- Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, Etoh T, Mihara R, Nakano M, Ruzicka T. Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121-1130.e7. doi: 10.1016/j.jaci.2018.03.018. Epub 2018 May 10.
- Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, Galus R, Etoh T, Mihara R, Yoshida H, Stewart J, Kabashima K; XCIMA Study Group. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056/NEJMoa1606490.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nemolizumab | Monoclonal antibody | 0.1 mg/kg | Subcutaneous |
| Subject | Nemolizumab | Monoclonal antibody | 0.5 mg/kg | Subcutaneous |
| Subject | Nemolizumab | Monoclonal antibody | 2 mg/kg | Subcutaneous |