Phase 3
Completed N=234
An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
Source: ClinicalTrials.gov NCT02326298 ↗Enrolled (actual)
234
Serious AEs
9.3%
Results posted
Aug 2018
Primary outcomePrimary: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 — 6.5; 66.5; 75.8 percentage of participants — p=<0.0001
◆ Published Evidence
Highly cited
154citations · ~19 / year
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).
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.
Linked Publications (4)
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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).
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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).
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Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies.
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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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 |
6.5; 66.5; 75.8 | <0.0001 sig |
| PRIMARY Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16 |
4.2; 47.0; 57.9 | <0.0001 sig |
| SECONDARY Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16 |
0.4; 35.8; 43.6 | <0.0001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
-3.3; -9.3; -10.2 | <0.0001 sig |
| SECONDARY Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48 |
52.7; 69.5 | — |
| SECONDARY Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 |
67.2; 87.1 | — |
Eligibility Criteria
Inclusion Criteria
- Provided informed consent
- Adult men or women >= 18 years
- Chronic plaque psoriasis for at least 6 months
- Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and Physician's Global Assessments score >= 3
- Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Erythrodermic, guttate, generalized pustular form of psoriasis
- History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
- Congestive heart failure
- History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
- Concurrent malignancy or a history of malignancy as described in the protocol
- History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug (in Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug
- Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02326298) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.