An Efficacy and Safety Study 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 when administered every 2 weeks.
Timeline
- Start
- 2014-12-16
- Primary completion
- 2016-03-08
- Completion
- 2018-10-24
Outcome
Met primary endpoint
registry Placebo Q2W (RS) vs CZP 200 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 28.962 (97.5% CI 6.968 to 120.371) NCT02326298 ↗
registry Placebo Q2W (RS) vs CZP 400 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 45.660 (97.5% CI 10.657 to 195.634) NCT02326298 ↗
registry Placebo Q2W (RS) vs CZP 200 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 20.116 (97.5% CI 3.699 to 109.399) NCT02326298 ↗
registry Placebo Q2W (RS) vs CZP 400 mg Q2W (RS); p <0.0001; Odds Ratio (OR) 31.143 (97.5% CI 5.687 to 170.548) NCT02326298 ↗
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 |