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SHP-141C

Phase 2

Plaque Type Psoriasis | Small Molecules | Dermatology |TetraLogic Pharmaceuticals Corporation|Trials Updated: Jul 11, 2014

SHP-141C development status

Highest phase Phase 2 (NCT02213861)
Phase scored for TLOGPhase 1
Registered trials 2 across 1 sponsor since Jul 2012

SHP-141C target and mechanism

ModalitySmall Molecules

Also known as SHAPE

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

SHP-141C clinical trials

SHP-141C · 1 trial · 1 indication

Phase 1 1
NCT01646567SHP-141C in Plaque Type PsoriasisPlaque Type Psoriasis
COMPLETED14 Analytics
PHASE1COMPLETED
SHP-141C in Plaque Type Psoriasis
Plaque Type PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in Local Plaque Severity Index (LPSI)
Baseline, day 15, day 33

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

Secondary Endpoints

The number of patients with adverse events
daily to and including Day33
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Study Design & Arms

AllocationNA
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SHP-141C & Placebo & Calcipotriol & Betamethasone ValerateEXPERIMENTALA 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.

Interventions

NameTypeDescription
SHP-141CDRUGTopical Cream
Placebo to SHP-141CDRUGPlacebo Topical Cream
Betamethasone ValerateDRUGTopical cream, 0.02%
CalcipotriolDRUGTopical cream, 0.005%
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

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. - ...

Countries:Australia
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