Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

NCT ID: NCT00245765

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-11-30

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.

Conditions

Chronic Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Subcutaneous injections of Placebo every 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching Placebo to Certolizumab Pegol

Certolizumab Pegol 200 mg

Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter

Group Type: EXPERIMENTAL

Certolizumab Pegol

Intervention Type: DRUG

• Pharmaceutical Form: solution for injection in pre-filled syringe
• Route of Administration: subcutaneous use

Certolizumab Pegol 400 mg

Subcutaneous injections of 400 mg every 2 weeks

Group Type: EXPERIMENTAL

Certolizumab Pegol

Intervention Type: DRUG

• Pharmaceutical Form: solution for injection in pre-filled syringe
• Route of Administration: subcutaneous use

Interventions

Certolizumab Pegol

• Pharmaceutical Form: solution for injection in pre-filled syringe
• Route of Administration: subcutaneous use

Intervention Type: DRUG

Placebo

Matching Placebo to Certolizumab Pegol

Intervention Type: OTHER

Other Intervention Names

Cimzia

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

Besançon, , France

Créteil, , France

Nice, , France

Paris, , France

Pierre-Bénite, , France

Saint-Etienne, , France

Berlin, , Germany

Bonn, , Germany

Essen, , Germany

Frankfurt, , Germany

Göttingen, , Germany

Hamburg, , Germany

Kiel, , Germany

Mainz, , Germany

Münster, , Germany

Countries

France; Germany

References

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 22413944 (View on PubMed)

Other Identifiers

2005-002141-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C87040

Identifier Type: -

Identifier Source: org_study_id