Raptiva in Palm and Sole Psoriasis

NCT00972543 | Terminated Phase 4 Results

• 1 other identifier: 28861
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in subjects that are candidates for phototherapy or systemic therapies. The rational of the trial is that psoriasis involving palms and/or soles is a painful condition associated with fissuring, scaling and in some instances with pustulation. Because of its localization, it is a disabling condition that limits dexterity and affects social interaction, leading to compromised quality of life; and this confers additional severity to that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a certain extent, the next step involves the addition of systemic treatments. Substances like methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and offer a new therapeutic approach. The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic treatments has been described in numerous case reports and in one placebo-controlled phase IV study. However, in all cases, the number of subjects included was low, and in most cases the trials were not prospectively designed. Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the validated PPPASI measure, it is necessary for scientific and ethical reasons to include a placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week open-label extended treatment period.

Conditions

Chronic Plaque Psoriasis

Keywords

Moderate to severe chronic plaque psoriasis; palms and/or soles; with or without pustules

Outcome Measures

Primary Outcomes (5)

• Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)

  Minimum possible score 0, maximum possible score 72.

  Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits

• Static Physician Global Assessment Hands and Feet (sPGA - H&F)

  Minimum possible score 0, maximum possible score 4.

  Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit

• Psoriasis Area and Severity Index (PASI)

  Minimum possible score 0, maximum possible score 72.

  Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits

• Static Physician Global Assessment (SPGA)

  The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse

  Measured at Screening, Day 0 and Day 7

• Dynamic Physician's Global Assessment of Change (dPGA)

  The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse

  Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits

Secondary Outcomes (30)

• Participants With Direct Physical Examination Abnormalities

  Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits

• Complaint Directed Physical Examinations

  Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)

• Heart Rate

  Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits

• Arterial Blood Pressure

  Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits

• Temperature

  Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits

Study Arms (2)

Raptiva

ACTIVE COMPARATOR

Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks

Biological: Efalizumab (Raptiva)

Placebo

PLACEBO COMPARATOR

Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks

Biological: Placebo

Interventions

Efalizumab (Raptiva) BIOLOGICAL

Double-blind phase 0.7mg/kg subcutaneously (sc), followed by 1mg/kg/wk sc for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks.

Also known as: Raptiva

Raptiva

Placebo BIOLOGICAL

Double-blind phase sc Placebo for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have moderate to severe chronic (disease history of at least 6 months from diagnosis) plaque psoriasis involving the palms and/or soles (PPPASI =/\>5) at screening, and must be candidates for phototherapy and systemic therapies.
• Subjects must be outpatients.
• Subjects must have stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period).
• Subjects must not have received any systemic psoriasis medication at least 14 days prior to the first administration of investigational medicinal product.
• Subjects must not have received any topical psoriasis medication at least 14 days prior to the first administration of investigational medicinal product (emollients are allowed, as well as low potency steroids to the face and/or groin).
• Subjects must be at least 18 years old at the time that the informed consent is obtained.
• Female subjects of childbearing potential must use an adequate method of contraception to prevent pregnancy and must agree to continue to practice adequate contraception for the duration of their participation in the study (up to the last safety follow up visit). For male subjects, it is mandatory to practice birth control during participation in the trial, as there are no data on the effect of Raptiva® on spermatogenesis. For the purposes of this trial, women of childbearing potential are defined as "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive." Adequate contraception is defined as two barrier methods, or one barrier method with spermicide, or an intrauterine device or use of the oral female contraceptive.
• Subjects must have discontinued all biological agents at least 3 months prior to the first study treatment injection.
• Subjects must have discontinued any investigational drug or treatment at least 3 months prior to study Day 0 and/or as per washout requirements from previous protocol.
• Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
• Subjects must have provided their written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent

You may not qualify if:

• Hypersensitivity to Raptiva®/matching placebo or to any of their excipients.
• Current use of any prohibited therapy (systemic or topical treatments for psoriasis, such as retinoids; immunosuppressive drugs such as methotrexate, cyclosporine A, azathioprine, or mycophenolate mofetil, or any other experimental drug).
• Previous or current exposure to Raptiva®.
• History of or ongoing alcohol or drug abuse.
• History of or ongoing opportunistic infection or other serious infection. This includes any infections from the following list: Pneumocystis carinii, cytomegalovirus organ infections, Candida albicans (excluding simple localised muco-cutaneous infections), mycobacterium infections, Cryptococcus neoformans, Toxoplasma gondii, herpes simplex (excluding localised oral or genital muco-cutaneous infection), herpes zoster (excluding simple shingle eruption), cryptosporidium, Isospora belli, coccidioidomycosis, aspergillosis, histoplasmosis, and nocardiosis. This also includes diagnoses requiring more than 2 weeks of therapy, such as endocarditis and osteomyelitis treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression of or prophylaxis for any diagnosis, the subject will be excluded.
• Seropositivity for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Subjects will undergo testing during screening; any subjects who are found to be seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded, and proper diagnosis and further therapy will be recommended.
• Presence of active tuberculosis.
• Presence or history of malignancy including lymphoproliferative disorders.
• Pregnancy or breast-feeding.
• History of hepatic cirrhosis, regardless of cause or severity.
• History or presence of thrombocytopenia, haemolytic anaemia, clinically significant anaemia, a white blood cell count \<4,000 cells/μL or \>14,000 cells/μL, a haematocrit (HCT) \<30%, a haemoglobin (Hgb) level \<11 g/dL, or a platelet count \<150,000 cells/μL.
• Hepatic enzyme levels =/\>3 times the upper limit of normal or serum creatinine level =/\>2 times the upper limit of normal.
• Vaccination with a live or live-attenuated vaccine within the 14 days prior to the first dose of investigational medicinal product.
• Any medical condition that, in the judgment of the Investigator, would jeopardise the subject's safety following exposure to investigational medicinal product (Raptiva® or placebo equivalent) or would significantly interfere with the subject's ability to comply with the provisions of this protocol.
• Other specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

MeSH Terms

Interventions

efalizumab

Results Point of Contact

• Title: Medical Responsible
• Organization: Merck Serono S.A., a division of Merck KGaA

service@merckgroup.com

+49-6151-75-5200

Study Officials

• Nicole Selenko-Gebauer, MD

  Merck Serono S.A., Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2009
• First Posted: September 7, 2009
• Study Start: September 1, 2008
• Primary Completion: May 1, 2009
• Last Updated: February 13, 2014
• Results First Posted: September 2, 2010

Record last verified: 2014-01