NCT00716144

Brief Summary

Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2

Geographic Reach
5 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

January 29, 2018

Completed
Last Updated

January 29, 2018

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

July 15, 2008

Results QC Date

March 10, 2017

Last Update Submit

June 28, 2017

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Psoriasis Area Severity Index (PASI)75 Success at Visit 6

    PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.

    Week 12 (Visit 6)

Secondary Outcomes (3)

  • PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit

    Week 1 to Week 20 (Visit 3 to Visit 8)

  • Investigator's Global Assessment (IGA) at Each Post Baseline Visit

    Week 1 to Week 20 (Visit 3 to Visit 8)

  • PASI75 at Each Post Baseline Visit Except Visit 6

    Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)

Study Arms (4)

A

ACTIVE COMPARATOR

Talarozole 0.5 mg

Drug: Talarozole

B

ACTIVE COMPARATOR

Talarozole 1.0 mg

Drug: Talarozole

C

ACTIVE COMPARATOR

Talarozole 2.0 mg

Drug: Talarozole

D

PLACEBO COMPARATOR

Talarozole matching Placebo

Drug: Talarozole

Interventions

TalarozoleDRUG

Oral Capsule Once Daily

Also known as: Rambazole, R115866
ABCD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Plaque Psoriasis with PASI greater than or equal to 10
  • Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy);

You may not qualify if:

  • Spontaneously improving or rapidly deteriorating plaque psoriasis
  • Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis
  • Subject was under treatment for a heart disorder or had a history of cardiovascular disease (excluding effectively controlled hypertension)
  • Any acute psychiatric condition, including an increased risk for suicide attempt, based on medical and psychiatric history
  • Previous use of a psoriasis vaccine or had participated in an investigational study of a psoriasis vaccine
  • Previous use of systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations
  • Previous use of any systemic immunomodulatory therapy known to affect psoriasis and NOT typically to decrease immune cell populations
  • Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within the previous four weeks
  • Pregnant or a nursing mother
  • Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test for human immunodeficiency virus (HIV), a history indicating adrenal cortex dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

GSK Investigational Site

Augsburg, Germany

Location

GSK Investigational Site

Berlin, Germany

Location

GSK Investigational Site

Dresden, Germany

Location

GSK Investigational Site

Frankfurt, Germany

Location

GSK Investigational Site

Hamburg, Germany

Location

GSK Investigational Site

Salzwedel, Germany

Location

GSK Investigational Site

Cork, Ireland

Location

GSK Investigational Site

Maastricht, Netherlands

Location

GSK Investigational Site

Nijmegen, Netherlands

Location

GSK Investigational Site

Korolyov, Russia

Location

GSK Investigational Site

Lipetsk, Russia

Location

GSK Investigational Site

Moscow, Russia

Location

GSK Investigational Site

Saint Petersburg, Russia

Location

GSK Investigational Site

Smolensk, Russia

Location

GSK Investigational Site

Veliky Novgorod, Russia

Location

GSK Investigational Site

Yaroslavl, Russia

Location

GSK Investigational Site

Aberdeen, United Kingdom

Location

GSK Investigational Site

Amersham, United Kingdom

Location

GSK Investigational Site

Coventry, United Kingdom

Location

GSK Investigational Site

Glasgow, United Kingdom

Location

GSK Investigational Site

Manchester, United Kingdom

Location

GSK Investigational Site

Norwich, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Interventions

R 115866

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 16, 2008

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 29, 2018

Results First Posted

January 29, 2018

Record last verified: 2017-05

Locations

DE(6)GB(6)NL(2)IE(1)RU(7)