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

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245765
• Other study ID #: C87040
• Secondary ID: 2005-002141-39
• Status: Completed
• Phase: Phase 2
• Start date: October 2005
• Est. completion date: November 2006

Study information

• Verified date: January 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

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

Other:
• Placebo
Matching Placebo to Certolizumab Pegol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (9)

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

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.Aca

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 D

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.Vene

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-contr

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

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-treatm — View 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,

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 Europ

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.; PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.	Week 12
Primary	Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12	The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema; 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)	Week 12
Secondary	Time to Psoriasis Activity and Severity Index 50 (PASI50)	Time to PASI50 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI50 during the Treatment Period.; This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).	During the 12-weeks Treatment Period
Secondary	Time to Psoriasis Activity and Severity Index 75 (PASI75)	Time to PASI75 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI75 during the Treatment Period.; This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).	During the 12-weeks Treatment Period
Secondary	Time to Relapse	Time to relapse is defined as the time elapsed between the last dose and when maximal improvement in PASI from Baseline was reduced by > 50 %. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).	During the 12-weeks Treatment Period
Secondary	Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.; PASI50 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %.	Week 12
Secondary	Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.; PASI90 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %.	Week 12
Secondary	Experience of a Rebound Effect Within 2 Months After Stopping Therapy	Rebound is defined as worsening of psoriasis over baseline value with more than 125 % or new pustular, erythrodermic or more inflammatory psoriasis within 2 months of stopping therapy.	Within 2 months of stopping therapy
Secondary	Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)	Week 12
Secondary	Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.	Baseline up to Week 12
Secondary	Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis		During the 12-week Treatment Period

External Links

•   Clinical Study Summary on UCB.com