ACT-128800 in Psoriasis | NCT00852670

Studies
ACT-128800 in Psoriasis

NCT00852670

Sponsor

Actelion

Status

Completed

Last Update Posted

Nov 13, 2009Estimated

Enrollment

66Actual

Phase

Phase 2

Conditions

Plaque Psoriasis

Interventions

ACT-128800
Placebo

Countries

Austria
France
Germany
Hungary
Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Feb 26, 2009

First Submission Date that Met QC Criteria

Feb 26, 2009

First Posted Date

Feb 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2009

Last Update Posted Date

Nov 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: ACT-128800
B	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACT-128800	Drug	ACT-128800 administered orally once daily	A
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Albrecht Georg Schmidt, MD	Actelion	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie		Graz		8036	Austria
University Klinik of Vienna

Intervention Browse Module

MeSH Terms

ID	Term
C550169	ponesimod

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided