ACT-128800 in Psoriasis

Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800, an S1P1 Receptor Agonist, Administered for 6 Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00852670

Enrollment

Registered

2009-02-27

Start date

2008-10-31

Completion date

2009-09-30

Last updated

2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Brief summary

This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis.

Interventions

DRUGACT-128800

ACT-128800 administered orally once daily

DRUGPlacebo

Matching placebo capsules administered orally once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified.

Exclusion criteria

* Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis. * Systemic or topical treatments for psoriasis other than emollients. * Ongoing bacterial, viral or fungal infections. * History or presence of malignancy. * Additional inclusion and

Design outcomes

Primary

Measure	Time frame
Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.	Baseline to week 6

Secondary

Measure	Time frame
Clear - almost clear Physician Global Assessment (PGA) at Week 6 visit.	Week 6

Countries

Austria, France, Germany, Hungary, Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026