Phase IV study to investigate neutrophil downregulation of Thy-1 by Raptiva® (Efalizumab) as a potential responder predictor in patients with moderate to severe plaque psoriasis - Responder Prediction Study

• Conditions: Moderate to severe chronic plaque psoriasis (PASI = 12) failing to respond to, or with a contraindication to, or intolerant to other systemic therapies including cyclosporine, methotrexate and Psoralen ultraviolet light A (PUVA); MedDRA version: 8.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2006-004547-35-DE
• Lead Sponsor: Serono GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult patient with moderate to severe chronic plaque psoriasis (PASI = 12) who has failed to respond to, or who has a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate and Psoralen ultraviolet light A (PUVA) according to SmPC

2. 18 to 75 years old

3. Body weight max. 120 kg

4. Discontinuation of any systemic psoriasis treatment prior to commencement of the study treatment. An appropriate washout period is required for these agents (e.g. for cyclosporin, corticosteroids, methotrexate, retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, and 6-MP); and for any systemic immunosuppressive treatment applied for psoriasis. The specific wash out requirements must be followed for each systemic therapy and a wash out period of at least one month prior to receiving the first dose of study drug (SD 0) is required, if not indicated otherwise.
Application of PUVA treatment must have been discontinued one month prior to receiving the first dose of study drug (SD 0); biologic agents must not have been applied within three months prior to receiving the first dose of study drug (SD 0)

5. Discontinuation of all high potency topical corticosteroid treatments for psoriasis at least 14 days prior to receiving the first dose of study drug (SD 0)

6. Discontinuation of any investigational drug or treatment prior to commencement of the study treatment. A washout period of two months is required for these agents prior to receiving the first dose of study drug (SD 0)

7. Treatment regimens of ß-blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to receiving the first dose of study drug (SD 0)

8. No required vaccination (e.g. tetanus, booster, influenza vaccine) at least 14 days prior to receiving the first dose of study drug (SD 0).

9. Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis

2. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies

3. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection

4. History of opportunistic infections (e.g., systemic fungal infections, parasites)

5. History of or ongoing active tuberculosis (TB) or other serious infections

6. History of clinically significant thrombocytopenia, bleeding disorders or a platelet count < 50,000

7. Application of any biologic agent within 3 months prior to receiving the first dose of study drug (SD 0)

8. Application of systemic treatments (see inclusion criteria) within 1month prior to receiving the first dose of study drug (SD 0)

9. Application of any systemic immunosuppressive treatment applied for any condition other than psoriasis within 1 month prior to receiving the first dose of study drug (SD 0)

10. UV/PUVA treatment within 1month prior to receiving the first dose of study drug (SD 0)

11. Application of any investigational drug or treatment less than 2 months ago prior to receiving the first dose of study drug (SD 0)

12. Application of live or killed virus or bacteria vaccines within 14 days prior to receiving the first dose of study drug (SD 0)

13. Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled

14. Diagnosis of hepatic cirrhosis, regardless of cause or severity

15. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year

16. History of drug abuse within the last 5 years

17. History of seropositivity for human immunodeficiency virus (HIV)

18. History of seropositivity for hepatitis B or C virus

19. WBC count <4,000/L or >14,000/L

20. Hepatic enzymes 3 times the upper limit of normal

21. Serum creatinine 2 times the upper limit of normal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate <br><br>- whether the decrease in the adhesion of psoriatic neutrophils to Thy-1 is a first sign of a successful treatment before the clinical improvement can be observed, and <br><br>- whether the failure of a significant decrease in the Thy-1-mediated adhesion during anti-psoriatic therapy is a predictor for patients who will not efficiently respond to the treatment<br>;Secondary Objective: To show efficacy of Raptiva in patients with moderate to severe plaque psoriasis<br><br>To collect safety data for Raptiva in patients with moderate to severe plaque psoriasis;Primary end point(s): PASI 75 at week 12<br><br>Sensitivity and specificity of inhibition of Thy-1- mediated adhesion of neutrophils as a biomarker to identify PASI 75 responders