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PPC-06

Phase 2

Psoriasis | Small molecule | Immunology |Dr. Reddy's Laboratories Ltd|Last Updated: Apr 1, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment426
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03421197A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)PHASE2 COMPLETED 426Jan 25, 2018Mar 30, 2020Apr 1, 202274 United States
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Study Endpoints
Primary Endpoints
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24
End of Week 24

The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index (PASI-75) The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.

Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1
End of Week 24

The Percentage of subjects who achieve the Investigator's Global Assessment (IGA) score of clear or almost clear (IGA score 0 or 1) Score Grade Definition 0 Clear: No signs of psoriasis 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PPC-06 400 mg QDEXPERIMENTALTepilamide Fumarate 400 mg once per day
PPC-06 400 mg BIDEXPERIMENTALTepilamide Fumarate 400 mg twice per day
PPC-06 600 mg BIDEXPERIMENTALTepilamide Fumarate 600 mg twice per day
Placebo BIDPLACEBO_COMPARATORWhite placebo tablet to mimic Tepilamide Fumarate
Interventions
NameTypeDescription
PPC-06 400 mg QDDRUGTepilamide Fumarate 400 mg tablet once per day
PPC-06 400 mg BIDDRUGTepilamide Fumarate tablets 400 mg twice per day
PPC-06 600 mgDRUGTepilamide Fumarate tablets 600 mg twice per day
PlaceboDRUGwhite tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites74

Inclusion Criteria: * Generally healthy males or non-pregnant females age ≥18 years at the time of screening (or who have reached the state minimum legal age of consent). * Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or s...

Countries:United States
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