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ACT-128800

Phase 2

Psoriasis | Small molecule | Immunology |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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment326
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01208090ACT-128800 in Patients With Moderate to Severe Chronic Plaque PsoriasisPHASE2 COMPLETED 326Oct 31, 2010Nov 30, 2012Mar 30, 202567 Austria, Belgium +15
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Study Endpoints
Primary Endpoints
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
Baseline to week 16
Secondary Endpoints
Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.
Baseline to week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Investigational drug - Dose 1EXPERIMENTAL -
Investigational drug - Dose 2EXPERIMENTAL -
Matching placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ACT-128800DRUGACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
PlaceboDRUGACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment. Exclusion Criteria: * Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than ps...

Countries:AustriaBelgiumBulgariaCzechiaDenmarkFranceHungaryItalyLithuaniaRomaniaRussiaSlovakiaSpainSwedenSwitzerlandUkraineUnited Kingdom
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