Trial · NCT00244842
Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis
NCT00244842, Phase 3, Completed, Aurinia Pharmaceuticals Inc.; results first posted 2023-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis. Trials, record NCT00244842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00244842
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis
- NCT number
- NCT00244842
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 451 participants, actual
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Conditions
- Psoriasis
- Interventions
- voclosporin, Placebo
- First posted
- 2005-10-27
- Last updated
- 2023-03-27
- Results first posted
- 2023-03-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. | Twelve Weeks | Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin. |
| Secondary | To Investigate the Safety and Tolerability of Voclosporin. | Twelve and twenty four weeks | |
| Secondary | To Investigate the Pharmacokinetics and Pharmacodynamics of Voclosporin After Chronic Dosing in a Subset of Subjects. | Twelve and twenty four weeks | |
| Secondary | To Evaluate the Effect of Voclosporin on Subject Quality of Life | Twelve and twenty four weeks |
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 | Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. | Twelve Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Investigate the Safety and Tolerability of Voclosporin. | Twelve and twenty four weeks | |||
| SECONDARY | To Investigate the Pharmacokinetics and Pharmacodynamics of Voclosporin After Chronic Dosing in a Subset of Subjects. | Twelve and twenty four weeks | |||
| SECONDARY | To Evaluate the Effect of Voclosporin on Subject Quality of Life | Twelve and twenty four weeks |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. | Placebo | 4 | Participants | ||
| Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. | Voclosporin 0.2 | 14 | Participants | ||
| Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. | Voclosporin 0.3 | 26 | Participants | ||
| Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. | Voclosporin 0.4 | 44 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo 1 | 115 | |
| Overall Study | STARTED | ISA247 2 | 107 | |
| Overall Study | STARTED | ISA247 3 | 113 | |
| Overall Study | STARTED | ISA247 4 | 116 | |
| Overall Study | COMPLETED | Placebo 1 | 92 | |
| Overall Study | COMPLETED | ISA247 2 | 76 | |
| Overall Study | COMPLETED | ISA247 3 | 91 | |
| Overall Study | COMPLETED | ISA247 4 | 83 | |
| Overall Study | NOT COMPLETED | Placebo 1 | 23 | |
| Overall Study | NOT COMPLETED | ISA247 2 | 31 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events84
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 115 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Voclosporin 0.2 | 2 | 107 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Voclosporin 0.3 | 4 | 113 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Voclosporin 0.4 | 12 | 116 | 14 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 4 | 115 | 4 |
| other | Vomiting | Gastrointestinal disorders | Voclosporin 0.2 | 3 | 107 | 3 |
| other | Vomiting | Gastrointestinal disorders | Voclosporin 0.3 | 2 | 113 | 2 |
| other | Vomiting | Gastrointestinal disorders | Voclosporin 0.4 | 7 | 116 | 8 |
| other | Blood pressure increased | Vascular disorders | Placebo | 5 | 115 | 7 |
| other | Blood pressure increased | Vascular disorders | Voclosporin 0.2 | 4 | 107 | 4 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 115 |
| Total, all-cause mortality | Voclosporin 0.2 | 0 | 107 |
| Total, all-cause mortality | Voclosporin 0.3 | 1 | 113 |
| Total, all-cause mortality | Voclosporin 0.4 | 0 | 116 |
| Total, other adverse events | Placebo | 62 | 115 |
| Total, other adverse events | Voclosporin 0.2 | 67 | 107 |
| Total, other adverse events | Voclosporin 0.3 | 65 | 113 |
| Total, other adverse events | Voclosporin 0.4 | 80 | 116 |
| Total, serious adverse events | Placebo | 4 | 115 |
| Total, serious adverse events | Voclosporin 0.2 | 2 | 107 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT00244842
GET https://conductscience.org/api/trials/v1/NCT00244842/events?page=2