Trial · NCT03288324
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
NCT03288324, Phase 1, Phase 2, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2024-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus. Trials, record NCT03288324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03288324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
- NCT number
- NCT03288324
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Cutaneous Lupus, Systemic Lupus Erythematosus
- Interventions
- Tofacitinib
- First posted
- 2017-09-20
- Last updated
- 2026-03-03
- Results first posted
- 2024-07-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oral Clearance (CL/F) (Cohort 1 Only) | Day 5 | Apparent total clearance of the drug from plasma after oral administration |
| Secondary | Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | weeks 4, 8 and 24 compared to baseline. | Proportion of subjects who achieve a skin response per the validated CLASI The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score consists of two scores. The first summarizes the activity of the disease while the second is a measure of the damage done by the disease. The Activity Score range is 0-70 with the maximum score (70) indicating the worst outcome. The Damage Score range is 0-80 with the maximum score (80) indicating the worst outcome. |
| Secondary | AUCt (Cohort 1 Only) | Day 5 | Area under the plasma concentration-time curve linear scale Median Concentration (ng/mL) per nominal time 0-8 hours. |
| Secondary | Cmax (Cohort 1 Only) | Day 5 | Maximum (or peak) plasma concentration of Tofacitinib |
| Secondary | Tmax (Cohort 1 Only) | Day 5 | Time to reach maximum (peak) plasma concentration following administration of Tofacitinib |
| Secondary | Vz/F (Cohort 1 Only) | Day 5 | Apparent volume of distribution during terminal phase after non-intravenous administration |
| Secondary | Half-life of Tofacitinib (Cohort 1 Only) | Day 5 | half-life of Tofacitinib |
| Secondary | Safety of Tofacitinib: Total Number of Adverse Events is Reported (Cohorts 1 and 2) | 76 weeks | Rate and severity of adverse events and lab abnormalities experienced by participants in both cohorts of the research study. |
| Other | Steroid Dose Comparison at 72 Weeks | 72 weeks | Assess steroid sparing properties of Tofacitinib by comparing doses to baseline and rate of steroid discontinuation |
| Other | Change in SLE Disease Activity Index (SLEDAI) Score | 72 weeks | Measure Tofacitinib impact on disease activity The SLEDAI (version 2k) was completed and its MC domain (range:0-6) and extra-MC (range: 0-99) scores calculated. SLEDAI summary scores can be interpreted as following: 1-5 mild disease activity, 6-10 moderate disease activity, and 11 and more severe disease activity27, range: 0-105), with higher scores indicating higher activity |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Oral Clearance (CL/F) (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | (L/hr) | GEOMETRIC_MEAN |
| SECONDARY | Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | weeks 4, 8 and 24 compared to baseline. | score on a scale | MEAN | |
| SECONDARY | AUCt (Cohort 1 Only) | Day 5 | (ng.hr/mL) | GEOMETRIC_MEAN | |
| SECONDARY | Cmax (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Tmax (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | hr | MEDIAN |
| SECONDARY | Vz/F (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | L | GEOMETRIC_MEAN |
| SECONDARY | Half-life of Tofacitinib (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | hr | MEAN |
| SECONDARY | Safety of Tofacitinib: Total Number of Adverse Events is Reported (Cohorts 1 and 2) | 76 weeks | total adverse events | NUMBER | |
| OTHER_PRE_SPECIFIED | Steroid Dose Comparison at 72 Weeks | 72 weeks | Patients who completed 72 wks of study period | mg | MEAN |
| OTHER_PRE_SPECIFIED | Change in SLE Disease Activity Index (SLEDAI) Score | 72 weeks | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Oral Clearance (CL/F) (Cohort 1 Only) | Cohort 1 | 28.4 | Geometric Coefficient of Variation 23.5 | (L/hr) | |
| Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | Cohort 1 & Cohort 2 | Baseline | 16.55 | Standard Deviation 8.03 | score on a scale |
| Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | Cohort 1 & Cohort 2 | Week 4 | 10.91 | Standard Deviation 8.4 | score on a scale |
| Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | Cohort 1 & Cohort 2 | Week 8 | 8.64 | Standard Deviation 7.8 | score on a scale |
| Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | Cohort 1 & Cohort 2 | Week 24 | 8.82 | Standard Deviation 7.9 | score on a scale |
| AUCt (Cohort 1 Only) | Cohort 1 | 176 | Geometric Coefficient of Variation 23.5 | (ng.hr/mL) | |
| Cmax (Cohort 1 Only) | Cohort 1 | 51.7 | Geometric Coefficient of Variation 21.6 | (ng/mL) | |
| Tmax (Cohort 1 Only) | Cohort 1 | 1 | Full Range .5 to 2 | hr | |
| Vz/F (Cohort 1 Only) | Cohort 1 | 85.2 | Geometric Coefficient of Variation 25.6 | L | |
| Half-life of Tofacitinib (Cohort 1 Only) | Cohort 1 | 2.1 | Standard Deviation 0.321 | hr |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 & Cohort 2 | 12 | |
| Overall Study | COMPLETED | Cohort 1 & Cohort 2 | 11 | |
| Overall Study | NOT COMPLETED | Cohort 1 & Cohort 2 | 1 |
Source ClinicalTrials.gov
Adverse events45
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 | Abdominal tenderness | Gastrointestinal disorders | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Acne | Skin and subcutaneous tissue disorders | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Bronchitis | Infections and infestations | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Burns second degree | Injury, poisoning and procedural complications | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Chlamydial infection | Infections and infestations | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Conjunctival haemorrhage | Eye disorders | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Depression | Psychiatric disorders | Cohort 1 and 2 | 1 | 11 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1 and 2 | 2 | 11 | 2 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 and 2 | 0 | 11 |
| Total, other adverse events | Cohort 1 and 2 | 9 | 11 |
| Total, serious adverse events | Cohort 1 and 2 | 1 | 11 |
Source ClinicalTrials.gov
Papers0
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/NCT03288324
GET https://conductscience.org/api/trials/v1/NCT03288324/results?page=2