A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

Summary

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.

Timeline

Start

2014-12-15

Primary completion

2016-01-05

Completion

2018-09-12

Outcome

Met primary endpoint

registry Placebo Q2W (RS) vs CZP 200 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 33.405 (97.5% CI 9.965 to 111.983) NCT02326272 ↗

registry Placebo Q2W (RS) vs CZP 400 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 36.212 (97.5% CI 10.686 to 122.713) NCT02326272 ↗

registry Placebo Q2W (RS) vs CZP 200 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 106.225 (97.5% CI 9.572 to 1178.843) NCT02326272 ↗

registry Placebo Q2W (RS) vs CZP 400 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 133.163 (97.5% CI 11.904 to 1489.578) NCT02326272 ↗

Publications

• Results Gottlieb AB, Blauvelt A, Thaci D, Leonardi CL, Poulin Y, Drew J, Peterson L, Arendt C, Burge D, Reich K. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018 Aug;79(2):302-314.e6. doi: 10.1016/j.jaad.2018.04.012. Epub 2018 Apr 13.
• Gisondi P, Gottlieb AB, Elewski B, Augustin M, McBride S, Tsai TF, de la Loge C, Fierens F, Lopez Pinto JM, Tilt N, Lebwohl M. Long-Term Health-Related Quality of Life in Patients with Plaque Psoriasis Treated with Certolizumab Pegol: Three-Year Results from Two Randomised Phase 3 Studies (CIMPASI-1 and CIMPASI-2). Dermatol Ther (Heidelb). 2023 Jan;13(1):315-328. doi: 10.1007/s13555-022-00861-4. Epub 2022 Dec 13.
• Gordon KB, Warren RB, Gottlieb AB, Blauvelt A, Thaci D, Leonardi C, Poulin Y, Boehnlein M, Brock F, Ecoffet C, Reich K. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021 Apr;184(4):652-662. doi: 10.1111/bjd.19393. Epub 2020 Sep 9.
• Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Certolizumab Pegol	Protein / enzyme biologic	200 mg	Subcutaneous
Subject	Certolizumab Pegol	Protein / enzyme biologic	400 mg	Subcutaneous

Indications