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RA-18C3

Phase 2

Acne Vulgaris | Small molecule | Dermatology |Johnson & Johnson|Last Updated: Mar 30, 2025

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01474798Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne VulgarisPHASE2 COMPLETED 11Feb 29, 2012Dec 31, 2012Mar 30, 20253 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability
100 days

Incidence and type of adverse clinical events

Secondary Endpoints
RA-18C3 pharmacokinetics
70 days
Facial acne lesion count
56 days
Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts
56 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RA-18C3EXPERIMENTAL -
Interventions
NameTypeDescription
RA-18C3DRUGFor subjects weighing 27-53 kg: 100 mg (1 ml) administered every three weeks by subcutaneous injection. For subjects weighing \> 53 kg: 200 mg (2 ml) administered every three weeks by subcutaneous injection.
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Eligibility Criteria
Age Range18 Years — 30 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Age: ≥ 18 2. Moderate to moderately severe inflammatory acne vulgaris: * Investigator's Global Assessment grade of ≥ 3 and, * ≥ 15 inflammatory lesions (no more than 6 nodules) and, * ≥ 15 non-inflammatory lesions 3. Four week washout period for topical and oral ant...

Countries:United States
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