SHP-141C in Plaque Type Psoriasis

NCT01646567 | Completed Phase 1

• 1 other identifier: SHP-141C-002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plaque Type Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Local Plaque Severity Index (LPSI)

  Measurement of plaque severity including erythema, induration, and desquamation.

  Baseline, day 15, day 33

Secondary Outcomes (1)

• The number of patients with adverse events

  daily to and including Day33

Study Arms (1)

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

EXPERIMENTAL

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; Drug: Placebo to SHP-141C; Drug: Betamethasone Valerate; Drug: Calcipotriol

Interventions

SHP-141C DRUG

Topical Cream

Also known as: SHAPE

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

Placebo to SHP-141C DRUG

Placebo Topical Cream

Also known as: Placebo to SHAPE

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

Betamethasone Valerate DRUG

Topical cream, 0.02%

Also known as: Celestone-M

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

Calcipotriol DRUG

Topical cream, 0.005%

Also known as: Daivonex

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• 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).
• 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.

Sponsors & Collaborators

• TetraLogic Pharmaceuticals: lead

Study Sites (1)

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Betamethasone Valerate; calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Peter Foley

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 20, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

AU (1)