Trial · NCT00716144
Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
NCT00716144, Phase 2, Completed, Stiefel, a GSK Company; results first posted 2018-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis. Trials, record NCT00716144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00716144
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
- NCT number
- NCT00716144
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 176 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Psoriasis
- Interventions
- Talarozole
- First posted
- 2008-07-16
- Last updated
- 2018-01-29
- Results first posted
- 2018-01-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | Week 12 (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 | 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) | 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. |
| Secondary | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Week 1 to Week 20 (Visit 3 to Visit 8) | 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. |
| Secondary | PASI75 at Each Post Baseline Visit Except Visit 6 | Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | Week 12 (Visit 6) | Modified Intent-to-Treat (MITT) population. MITT population comprised of all randomized participants who took study medication and provided post-Visit 2 efficacy data (i.e., had one on-therapy follow-up visit). | Participants | NUMBER |
| SECONDARY | 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) | MITT population. | Participants | NUMBER |
| SECONDARY | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Week 1 to Week 20 (Visit 3 to Visit 8) | MITT population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the MITT Population. | Participants | NUMBER |
| SECONDARY | PASI75 at Each Post Baseline Visit Except Visit 6 | Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6) | MITT population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | Placebo | 4 | Participants | ||
| Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | R115866 0.5 mg | 7 | Participants | ||
| Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | R115866 1.0 mg | 4 | Participants | ||
| Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | R115866 2.0 mg | 5 | Participants | ||
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Placebo | Visit 3 | 0 | Participants | |
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | R115866 0.5 mg | Visit 3 | 0 | Participants | |
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | R115866 1.0 mg | Visit 3 | 0 | Participants | |
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | R115866 2.0 mg | Visit 3 | 0 | Participants | |
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Placebo | Visit 4 | 2 | Participants | |
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | R115866 0.5 mg | Visit 4 | 0 | Participants |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | STARTED | R115866 0.5 mg | 45 | |
| Overall Study | STARTED | R115866 1.0 mg | 45 | |
| Overall Study | STARTED | R115866 2.0 mg | 45 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | COMPLETED | R115866 0.5 mg | 38 | |
| Overall Study | COMPLETED | R115866 1.0 mg | 33 | |
| Overall Study | COMPLETED | R115866 2.0 mg | 33 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | R115866 0.5 mg | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Coagulopathy | Blood and lymphatic system disorders | Placebo | 2 | 41 | |
| other | Coagulopathy | Blood and lymphatic system disorders | R115866 0.5 mg | 3 | 45 | |
| other | Coagulopathy | Blood and lymphatic system disorders | R115866 1.0 mg | 1 | 45 | |
| other | Coagulopathy | Blood and lymphatic system disorders | R115866 2.0 mg | 2 | 45 | |
| other | Dry eye | Eye disorders | Placebo | 1 | 41 | |
| other | Dry eye | Eye disorders | R115866 0.5 mg | 3 | 45 | |
| other | Dry eye | Eye disorders | R115866 1.0 mg | 6 | 45 | |
| other | Dry eye | Eye disorders | R115866 2.0 mg | 3 | 45 | |
| other | Cheilitis | Gastrointestinal disorders | Placebo | 0 | 41 | |
| other | Cheilitis | Gastrointestinal disorders | R115866 0.5 mg | 10 | 45 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 41 |
| Total, all-cause mortality | R115866 0.5 mg | 0 | 45 |
| Total, all-cause mortality | R115866 1.0 mg | 0 | 45 |
| Total, all-cause mortality | R115866 2.0 mg | 0 | 45 |
| Total, other adverse events | Placebo | 20 | 41 |
| Total, other adverse events | R115866 0.5 mg | 34 | 45 |
| Total, other adverse events | R115866 1.0 mg | 38 | 45 |
| Total, other adverse events | R115866 2.0 mg | 37 | 45 |
| Total, serious adverse events | Placebo | 1 | 41 |
| Total, serious adverse events | R115866 0.5 mg | 1 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00716144
GET https://conductscience.org/api/trials/v1/NCT00716144/results?page=2