SHP-141C in Plaque Type Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01646567
First received: July 11, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis.


Condition Intervention Phase
Plaque Type Psoriasis
Drug: SHP-141C
Drug: Placebo to SHP-141C
Drug: Betamethasone Valerate
Drug: Calcipotriol
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay.

Resource links provided by NLM:


Further study details as provided by TetraLogic Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in Local Plaque Severity Index (LPSI) [ Time Frame: Baseline, day 15, day 33 ] [ Designated as safety issue: No ]
    Measurement of plaque severity including erythema, induration, and desquamation.


Secondary Outcome Measures:
  • The number of patients with adverse events [ Time Frame: daily to and including Day33 ] [ Designated as safety issue: Yes ]
    Adverse event data for each subject will be collected.


Enrollment: 14
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate
A 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses.
Drug: SHP-141C
Topical Cream
Other Name: SHAPE
Drug: Placebo to SHP-141C
Placebo Topical Cream
Other Name: Placebo to SHAPE
Drug: Betamethasone Valerate
Topical cream, 0.02%
Other Name: Celestone-M
Drug: Calcipotriol
Topical cream, 0.005%
Other Name: Daivonex

Detailed Description:

Psoriasis is a chronic, relapsing immunoinflammatory disorder. Chronic plaque psoriasis is the most common (85% - 90%) type. Cutaneous features of individual plaques include circular with centrifugal expansion, induration with sharp demarcation from surrounding skin, erythema and hyperkeratosis. Psoriasis has a negative impact on physical and mental aspects of life that is similar to other major chronic conditions. The modalities of psoriasis treatments can be divided into four main categories: topical, phototherapy, systemic drug therapies and systemic biological treatments. The currently available treatments for psoriasis result in either disease suppression or disease remission.There are many treatment options for the management of psoriasis using topical modalities; however all are lacking with respect to patient satisfaction and durability of treatment. Most current topical treatments, and many treatments in development, are based on modifications of a steroid structure or on Vitamin D. Recent research has identified a broad role for histone deacetylase (HDAC) proteins in numerous signaling pathways critical to cancer cell survival, such as epigenetic inheritance, gene regulation, mitosis,signal transduction and importantly, inflammation. Theoretically modulation of HDAC could lead to clinical benefit in inflammatory diseases.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mild to moderate chronic plaque-type psoriasis.
  2. psoriasis of at least one year.
  3. Stable disease for at least two weeks prior to the commencement of study treatment.
  4. One nominated target lesions must have areas of at least 86 x 57 mm2.
  5. BMI of less than 35 kg/m2. -

Exclusion Criteria:

  1. Dermatological Conditions

    • Subjects with erythrodermic, guttate, palmar, plantar or generalised pustular forms of psoriasis.
    • Subjects with scalp, palmar or plantar psoriasis only.
    • Subjects with any skin condition other than psoriasis, in particular eczema, cutaneous infections, significant sun damage or an inherited skin disorder (other than psoriasis).
  2. Concurrent Medical Conditions

    • History of clinically significant intercurrent disease of any type (other than psoriasis).
    • A history of moderate or severe asthma during the last 10 years.
    • Major chronic inflammatory disease .
    • Congenital immunodeficiency or cancer prone syndrome.
    • History of abnormal bleeding tendencies or thrombophlebitis, or a history of Hepatitis B, Hepatitis C or HIV infection.
    • History of malignancy (other than adequately treated skin carcinoma or carcinoma-in-situ of the cervix).
  3. Laboratory Status

    • Any evidence of organ dysfunction, which is confirmed on re-examination to be clinically significant (i.e. in the opinion of the Medical Officer would jeopardise the safety of the subject or impact on the validity of the study results),
    • A creatinine clearance of less than 75 mL/min.
    • Liver function test > 1.5 x upper limit of normal other than an isolated bilirubin.
    • Hepatitis B surface antigen, Hepatitis C antibody, HIV antibodies.
  4. Treatment with any of the following within 4 weeks prior to the commencement of study treatment and for the duration of the study:

    • Systemic retinoids.
    • Immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine, thioguanine prednisone, prednisolone, hydroxyurea or mycophenolate mofetil).
    • Phototherapy or photochemotherapy.
    • High potency topical corticosteroids.
    • "Alternative medicine" treatments for psoriasis.
    • Prolonged sun exposure or tanning bed use, which may in the opinion of the Investigator, modify disease activity.
  5. Topical treatment of the 2 target lesions with any of the following within 2 weeks prior to commencement of study treatment and for the duration of the study

    • Moderate potency topical corticosteroids.
    • Vitamin D analogues and topical retinoids.
    • Keratolytics, coal tar and dithranol.
  6. Concurrent Medications Subjects have received or anticipate receiving a new medicine (prescription, over-the-counter or herbal), given systemically or topically, within 14 days prior to the start of dosing. Subjects may be enrolled if stable on existing therapy (having been on it for at least 60 days) as determined by the Principal Investigator.
  7. Hypersensitivity History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations or other topical agents. A known hypersensitivity to lignocaine, or all surgical dressings that may be used in the study procedures.
  8. Females who are lactating, pregnant or planning to become pregnant.
  9. Drug and Alcohol Abuse History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug and alcohol screen for drugs of abuse and alcohol.
  10. Psychiatric Disorder History of any psychiatric illness which may impair the ability to provide written informed consent
  11. Participation in a research study within 30 days of the start of dosing.
  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: NCT01646567

Locations
Australia, Victoria
Nucleus Network Limited
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
TetraLogic Pharmaceuticals
Investigators
Principal Investigator: Peter Foley The Alfred
  More Information

No publications provided

Responsible Party: TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01646567     History of Changes
Other Study ID Numbers: SHP-141C-002
Study First Received: July 11, 2012
Last Updated: July 10, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by TetraLogic Pharmaceuticals:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone 17-Valerate
Betamethasone sodium phosphate
Calcipotriene
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on July 23, 2014