Phase 2
N=176
Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
Chronic Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00245765 ↗Enrolled (actual)
176
Serious AEs
4.6%
Results posted
May 2019
Primary outcome: Primary: Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12 — 6.8; 74.6; 82.8 percentage of subjects — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Certolizumab Pegol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12 |
6.8; 74.6; 82.8 | <0.001 sig |
| PRIMARY Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12 |
1.7; 52.5; 72.4 | <0.001 sig |
| SECONDARY Time to Psoriasis Activity and Severity Index 50 (PASI50) |
56.50; 21.00; 22.00 | — |
| SECONDARY Time to Psoriasis Activity and Severity Index 75 (PASI75) |
77.50; 42.50; 55.50 | — |
| SECONDARY Time to Relapse |
NA; 22.14; 20.14 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 |
11.9; 86.4; 93.1 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 |
1.7; 39.0; 46.6 | — |
| SECONDARY Experience of a Rebound Effect Within 2 Months After Stopping Therapy |
15.3; 1.7; 1.7 | — |
| SECONDARY Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12 |
28.8; 7.1; 5.6 | — |
| SECONDARY Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12 |
3.2; 18.3; 22.6 | — |
| SECONDARY Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis |
42.0; 59.5; 49.0 | — |
Summary
A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.
Eligibility Criteria
Inclusion Criteria
- Adult men and women > 18 years
- Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
- Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
- Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
Exclusion Criteria
- Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
- A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
- White blood cell counts less than 4000/mm^3 or more than 20000/mm^3
- Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- Systemic Lupus
- Non respect of adequate wash out periods for treatments that might have an impact on the disease
- Any associated disease that could be impacted by the study treatment intake
- Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Data sourced from ClinicalTrials.gov (NCT00245765). 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.