ACT-128800 in Psoriasis

This study has been completed.

Sponsor:

Information provided by:

Actelion

ClinicalTrials.gov Identifier:

NCT00852670

First received: February 26, 2009

Last updated: November 11, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2009

Last Updated Date

November 11, 2009

Start Date ^ICMJE

October 2008

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit. [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00852670 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

"Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ACT-128800 in Psoriasis

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Plaque Psoriasis

Intervention ^ICMJE

Drug: ACT-128800
ACT-128800 administered orally once daily
Drug: Placebo
Matching placebo capsules administered orally once daily

Study Arm (s)

Experimental: A
Intervention: Drug: ACT-128800
Placebo Comparator: B
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, France, Germany, Hungary, Serbia

Administrative Information

NCT Number ^ICMJE

NCT00852670

Other Study ID Numbers ^ICMJE

AC-058A200

Has Data Monitoring Committee

Yes

Responsible Party

Sponsor, Actelion

Study Sponsor ^ICMJE

Actelion

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Albrecht Georg Schmidt, MD

Actelion

Information Provided By

Actelion

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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