Uncontrolled, open Phase IIa study to investigate efficacy and safety of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis (PPP) - PPP Study

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-003922-70-DE
• Date of registration: 08/08/2007
• Prospective Registration: Yes
• Primary sponsor: Technische Universität Dresden
• Public title: Uncontrolled, open Phase IIa study to investigate efficacy and safety of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis (PPP) - PPP Study
• Scientific title: Uncontrolled, open Phase IIa study to investigate efficacy and safety of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis (PPP) - PPP Study
• Date of first enrolment: 28/11/2007
• Target sample size: 42
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003922-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adult patient with (at least 6 months or longer) moderate to severe palmoplantar pustular psoriasis with or without psoriasis at other sites
2. PGA rating of moderate (4), severe (5) or very severe (6) for palmoplantar pustular psoriasis with at least ten fresh pustules at screening visit and baseline
3. Age 18 to 75 years
4. Body weight £125 kg
5. Naïve to efalizumab treatment
6. 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 (Study Day 0 = 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)
7. 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)
8. Discontinuation of any investigational drug or treatment prior to commencement of the study treatment. A washout period of six months is required for these agents prior to receiving the first dose of study drug (SD 0)
9. Treatment regimens of b 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)
10. No required vaccination (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to receiving the first dose of study drug (SD 0).
11. Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
12. Willingness to participate in photo documentation
13. For women of childbearing potential: Use of an acceptable method of contraception (implants, oral contraceptives, intrauterine device, sterilization or sterilized partner) to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and up to 3 months after the last dose of efalizumab
14. Agreement to participate in the study
15. Signed informed consent
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 chronic plaque 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. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded
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 hemolytic anemia
7. Previous exposure to efalizumab
8. Application of any biologic agent within 3 months prior to receiving the first dose of study drug (SD 0)
9. Application of systemic treatments within 3 months prior to receiving the first dose of study drug (SD 0)
10. Application of any systemic immunosuppressive treatment applied for any condition other than psoriasis within one month prior to receiving the first dose of study drug (SD0)
11. UV/PUVA treatment within 1 month prior to receiving first dose of study drug (SD 0)
12. Application of any investigational drug or treatment less than six months ago prior to receiving the first dose of study drug (SD 0)
13. Application of live or killed virus or bacteria vaccines within 14 days prior to receiving the first dose of study drug (SD 0)
14. 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
15. Diagnosis of hepatic cirrhosis, regardless of cause or severity
16. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
17. History of drug abuse within the last 5 years
18. History of seropositivity for human immunodeficiency virus (HIV)
19. History of seropositivity for hepatitis B or C virus
20. WBC count <4,000µ/L or >14,000/µL
21. Hematocrit (HCT) <30% or hemoglobin (Hgb) level <11 g/dL
22. Platelet count <150,000 cells/µL
23. Hepatic enzymes >3 times the upper limit of normal
24. Serum creatinine >2 times the upper limit of normal
25. Pregnancy or lactation
26. Any medical condition that, in the judgment of the investigator, would jeopardize the patient’s safety following exposure to study drug
27. Patient unwilling or unable to follow the protocol requirements


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

moderate to severe palmoplantar pustular psoriasis
MedDRA version: 9.1 Level: LLT Classification code 10037159 Term: Psoriasis pustular

Intervention(s)

Trade Name: Raptiva
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Efalizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Primary endpoint:
Number of fresh pustules (relative change at week 12 compared to baseline) Secondary efficacy outcome measures include:
- The proportion of patients who achieve a PGA rating of absence of disease (1), very mild disease (2), or mild disease (3) at Day 84
- The proportion of patients who achieve a PGA rating of absence of disease (1), very mild disease (2), or mild disease (3) at Day 42
- The change from Day 0 to Day 84 in the following measures: DLQI, PAGA, PP-PASI, PASI

Secondary Objective: To collect safety data for efalizumab in patients with moderate to severe palmoplantar pustular psoriasis

Main Objective: To evaluate efficacy of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis

Secondary ID(s)

TUD-PPPDD1-021