Clinical trial NCT00245765: Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
Official title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: chronic plaque psoriasis, anti TNFα
CDP870, Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12
timeFrame: Week 12
measure: Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Time to Psoriasis Activity and Severity Index 50 (PASI50)
timeFrame: During the 12-weeks Treatment Period
measure: Time to Psoriasis Activity and Severity Index 75 (PASI75)
timeFrame: During the 12-weeks Treatment Period
measure: Time to Relapse
timeFrame: During the 12-weeks Treatment Period
measure: Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12
timeFrame: Week 12
measure: Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
timeFrame: Week 12
measure: Experience of a Rebound Effect Within 2 Months After Stopping Therapy
timeFrame: Within 2 months of stopping therapy
measure: Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12
timeFrame: Week 12
measure: Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12
timeFrame: Baseline up to Week 12
measure: Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis
timeFrame: During the 12-week Treatment Period
Other outcomes:
Locations:
city: Besancon
country: France
city: Creteil
country: France
city: Nice Cedex 3
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Saint-Etienne
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Göttingen
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Mainz
country: Germany
city: Munster
country: Germany
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Ortonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.
citation: Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.
citation: Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.
citation: Ortonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.
citation: Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.
citation: Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.
citation: Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.
citation: Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.
citation: Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.