ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: Placebo; Drug: ACT-128800

• Registration Number: NCT01208090
• Lead Sponsor: Actelion

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Study Start: 2010-10-31
• Primary Completion: 2012-10-31
• Study Completion: 2012-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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 psoriasis.
• Systemic or topical treatments for psoriasis other than emollients. Ongoing bacterial, viral or fungal infections.

History or presence of malignancy.

• Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	Placebo	-
Investigational drug - Dose 1	ACT-128800	-
Investigational drug - Dose 2	ACT-128800	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.	Baseline to week 16

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.	Baseline to week 16

Trial Locations

Locations (67)

Clinical Investigative Site 1006; 🇦🇹 Feldkirch, Austria

Clinical Investigative Site 1002; 🇦🇹 Graz, Austria

Clinical Investigative Site 1004; 🇦🇹 St. Polten, Austria

Clinical Investigative Site 1007; 🇦🇹 Vienna, Austria

Clinical Investigative Site 1001; 🇦🇹 Vienna, Austria

Clinical Investigative Site 1103; 🇧🇪 Brussels, Belgium

Clinical Investigative Site 1102; 🇧🇪 Edegem, Belgium

Clinical Investigative Site 1101; 🇧🇪 Liege, Belgium

Clinical Investigative Site 1205; 🇧🇬 Pleven, Bulgaria

Clinical Investigative Site 1204; 🇧🇬 Plovdiv, Bulgaria

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