Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Talarozole

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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);

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

Talarozole 0.5 mg

Talarozole 1.0 mg

Talarozole 2.0 mg

Talarozole matching Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of 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.

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

The IGA was used to assess the overall severity of a participant's plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant's plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.

PASI75 at Each Post Baseline Visit Except Visit 6

PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of 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.

Full Information

NCT ID

NCT00716144

First Posted

July 15, 2008

Last Updated

June 28, 2017

Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00716144

Brief Title

Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis

Official Title

A Randomized, Evaluator-Blind, Placebo-Controlled, Parallel-Group Dose-Ranging Study of the Safety and Efficacy of Oral R115866 and R115866 Placebo in the Treatment of Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 1, 2006 (undefined)

Primary Completion Date

May 1, 2007 (Actual)

Study Completion Date

May 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Active Comparator

Arm Description

Talarozole 0.5 mg

Arm Title

B

Arm Type

Active Comparator

Arm Description

Talarozole 1.0 mg

Arm Title

C

Arm Type

Active Comparator

Arm Description

Talarozole 2.0 mg

Arm Title

D

Arm Type

Placebo Comparator

Arm Description

Talarozole matching Placebo

Intervention Type

Drug

Intervention Name(s)

Talarozole

Other Intervention Name(s)

Rambazole, R115866

Intervention Description

Oral Capsule Once Daily

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Week 12 (Visit 6)

Secondary Outcome Measure Information:

Title

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

Description

PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of 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.

Time Frame

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

Title

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

Description

The IGA was used to assess the overall severity of a participant's plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant's plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.

Time Frame

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

Title

PASI75 at Each Post Baseline Visit Except Visit 6

Description

PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of 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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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); Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Augsburg

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

Country

Germany

Facility Name

GSK Investigational Site

City

Salzwedel

Country

Germany

Facility Name

GSK Investigational Site

City

Cork

Country

Ireland

Facility Name

GSK Investigational Site

City

Maastricht

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nijmegen

Country

Netherlands

Facility Name

GSK Investigational Site

City

Korolev

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Lipetsk

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novgorod

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Aberdeen

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Amersham

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Coventry

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Glasgow

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Norwich

Country

United Kingdom

Psoriasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial