Efficacy and Safety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic Plaque Psoriasis

This study has been terminated.
(Study has been termination early due to financial contraints.)
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00782613
First received: October 29, 2008
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

The primary objective of this study will be to evaluate the efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.

The secondary objective will be to evaluate the safety of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.

Tertiary objectives will be to provide visual documentation of the improvement of psoriatic plaques treated with ALT-2074 using digital photography, and to determine the extent of systemic absorption of topically applied ALT-2074 based on a pharmacokinetic measurement of blood concentration.


Condition Intervention Phase
Psoriasis
Drug: 4,4-dimethyl-benziso-2H-selenazine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Wafety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic

Resource links provided by NLM:


Further study details as provided by Synvista Therapeutics, Inc:

Primary Outcome Measures:
  • Efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Two psoriatic plaques of similar surface area and severity will be identified for each subject. ALT-2074 will be applied topically twice daily to 1 of the 2 target plaques, and the placebo control to the other plaque for a period of 28 days in amounts sufficient to cover the entire surface area of the target plaque, extending to 1 cm outside of the plaque border.
Drug: 4,4-dimethyl-benziso-2H-selenazine
ALT-2074 in a 0.5% cream formulation
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo in a cream formulation

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria to qualify for entry into the study:

  1. Men and women between 18 and 75 years old, inclusive.
  2. Clinical diagnosis of stable, chronic plaque psoriasis for at least 6 months prior to Visit 1.
  3. In otherwise good general health and free of any disease or physical condition which might impair evaluation of plaque psoriasis.
  4. Plaque psoriasis treatable area <10% BSA. (Subject palm size is equivalent to 1% of BSA.)
  5. Have 2 well-matched plaques (target plaques) of approximately 3 to 8 cm by 3 to 8 cm in size in areas on the right and left or front and back, at sites other than the knees, below the knees, elbows, head, face, scalp, palms, and intertriginous areas.
  6. A Combined Psoriasis Severity Score (CPSS) > 6 for each target plaque at Visit 1.
  7. Willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
  8. Able to understand and willing to comply with all study requirements, particularly the regimen for administration of study drug.
  9. Able to understand and willing to sign the Informed Consent Form.

Exclusion Criteria:

Any subject who meets any of the following criteria will not qualify for entry into the study:

  1. Women who are pregnant, lactating, planning to become pregnant, or women of child-bearing potential who have not successfully been using the same medically acceptable contraceptive methods over the previous 3 months, eg, oral contraceptive agents, intrauterine device (IUD), and barrier method plus spermicide.
  2. Clinical diagnosis of guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
  3. Use of emollients or moisturizers on areas to be treated within 24 hours prior to Visits 1 or 2.
  4. Use of topical antipsoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to Visit 2.
  5. Received systemic immunomodulatory therapy to treat psoriasis (eg, methotrexate, cyclosporine, alefacept, etanercept, infliximab, efalizumab, adalimumab) within 12 weeks prior to Visit 2.
  6. Received phototherapy (including laser), photochemotherapy, or systemic psoriasis therapy (eg, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to Visit 2.
  7. Recent history (within past 12 months) of alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1.5 oz distilled spirits).
  8. History of noncompliance to medical regimens or unwilling to comply with the study protocol.
  9. Participation in an investigational drug study within 30 days prior to Visit 2.
  10. Serious or unstable medical or psychological conditions that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782613

Locations
Israel
Ha'emek Medical Center
Afula, Israel
Kaplan Medical Center
Rechovot, Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
Synvista Therapeutics, Inc
  More Information

No publications provided

Responsible Party: Moshe Neuman Ph.D., Biomedical Research Design, Ltd.
ClinicalTrials.gov Identifier: NCT00782613     History of Changes
Obsolete Identifiers: NCT00757861
Other Study ID Numbers: ALT-2074-205
Study First Received: October 29, 2008
Last Updated: January 29, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Synvista Therapeutics, Inc:
Psoriasis
The primary objective of this study will be to evaluate the
efficacy of topical ALT-2074 applied twice daily for 28
days for treatment of chronic plaque psoriasis in adult
subjects.
The secondary objective will be to evaluate the safety
of topical ALT-2074 applied twice daily for 28 days for
treatment of chronic plaque psoriasis in adult subjects.
Tertiary objectives will be to provide visual documentation
of the improvement of psoriatic plaques treated with
ALT-2074 using digital photography, and to determine the
extent of systemic absorption of topically applied ALT-2074
based on a pharmacokinetic measurement of blood
concentration.

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014