Trial · NCT05048238
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
NCT05048238, Phase 1, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2025-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus. Trials, record NCT05048238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05048238
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
- NCT number
- NCT05048238
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Cutaneous Lupus
- Interventions
- Tofacitinib
- First posted
- 2021-09-17
- Last updated
- 2025-08-22
- Results first posted
- 2025-03-21
- Limitations and caveats
The protocol specified inferential statistics for the primary and some secondary endpoints. Given the small number of participants enrolled, no statistical testing was performed, and only descriptive statistics are presented.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Day 1 (pre-treatment) to Day 26 | At Day 0 and Day 25, skin was exposed to 10-80 mJ/cm2 UVB irradiation. At Day 1 and Day 26, erythema levels were measured with a Chroma Meter at each dose site and in an unexposed section. Skin biopsies at Day 1 and Day 26 were taken at the unexposed site and at the minimal erythema dose (MED) at Day 1. The percentage of apoptotic epidermal cells were determined in each skin biopsy sample by TUNEL staining. The percentage of UVB-induced apoptotic cells is defined as the difference between the percentage of apoptotic epidermal cells in the UVB-exposed biopsy at the MED and percentage of apoptotic epidermal cells in the unexposed biopsy at the same visit. Change in percentage of UVB-induced apoptotic epidermal cells is calculated as the difference in the percentage of UVB-induced apoptotic cells at Day 26 and at Day 1. |
| Secondary | Change in Minimal Erythema Dose (MED) Due to UVB | Day 1 (pre-treatment) to Day 26 | At Day 0 and Day 25, skin was exposed to 10-80 mJ/cm2 UVB irradiation. At Day 1 and Day 26, erythema levels were measured with a Chroma Meter at each dose site and in an unexposed section. The MED was defined as the dose that contained the lowest UVB exposure and the average redness reading that was at least 2.5 higher than the average redness reading in the unexposed skin. The possible values for MED ranged from 10 to 80 mJ/cm2. |
| Secondary | Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts. | Day 1 (pre-treatment) to Day 26 | Skin biopsies at Day 1 and Day 26 were taken at the unexposed site and at the site corresponding to the next higher UVB dose than the Day 26 MED. RNA was isolated and expression values were analyzed by RNA sequencing. UVB-induced expression is defined as the difference in expression measured in the biopsy exposed at the Visit 2 (Day 1) 1x minimal erythema dose (MED) and that measured in the unexposed biopsy. |
| Secondary | Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | Day 0 (pre-treatment) to Day 25 | CLASI is a validated, physician-based assessment tool used to measure cutaneous lupus severity. Severity is calculated based on disease activity (erythema and scale) and damage (dyspigmentation and scarring) for the cumulative areas of involved skin. CLASI activity score ranges from 0 to 70, with higher scores indicating increased disease severity. |
| Secondary | Change in CLASI Damage Score | Day 0 (pre-treatment) to Day 25 | CLASI is a validated, physician-based assessment tool used to measure cutaneous lupus severity. Damage is calculated based on dyspigmentation and scarring for the cumulative areas of involved skin. The CLASI damage score ranges from 0 to 56, with higher scores indicating worse damage to the skin due to lupus. |
| Secondary | Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Day 0 (pre-treatment) to Day 25 | Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 30 days. SLEDAI-2K total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present. |
| Secondary | Change in Severity Grade for Laboratory Tests From Grade 0 | Screening Visit through Day 40 | The study sites graded the severity of laboratory results for the study participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0. The NCI-CTCAE manual provides a common language to describe levels of severity, to analyze and interpret data, and to articulate the clinical significance of adverse events. Select laboratory results are incorporated into relevant adverse event criteria. |
| Secondary | Treatment-emergent Adverse Events by Severity | Day 2 to Day 40 | The study sites graded the severity of AEs experienced by the study participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0. The NCI-CTCAE manual provides a common language to describe levels of severity, to analyze and interpret data, and to articulate the clinical significance of all AEs. A treatment-emergent AE is defined as an increase in grade from the last assessment prior to a participant starting treatment at Day 2, or from the last post-baseline value that doesn't meet grading criteria. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 25.1. |
| Secondary | Treatment-emergent Adverse Events by Relationship to Tofacitinib | Day 2 to Day 40 | The relationship, or attribution, of an adverse event to the study therapy regimen or study procedure(s) was initially determined by the site investigator and recorded on the appropriate AE/SAE eCRF as not related, possibly related or related. Final determination of attribution for safety reporting was determined by sponsor. An AE assessed as possibly related or related was classified as related to the study therapy or procedure. A treatment-emergent AE is defined as an increase in grade from the last assessment prior to a participant starting treatment at Day 2, or from the last post-baseline value that doesn't meet grading criteria. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 25.1. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Day 1 (pre-treatment) to Day 26 | The Per Protocol 1 (PP1) population includes all participants who received any amount of tofacitinib and who completed phototests and skin biopsies at both baseline (Visits 1 and 2) and post-treatment (Visits 4 and 5) time points. Only individuals who completed at least 21 days of IP dosing had the post-treatment phototest. | percentage of epidermal cells | MEAN |
| PRIMARY | Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Day 1 (pre-treatment) to Day 26 | The Per Protocol 2 (PP2) population includes all PP1 participants with no protocol deviations that would impact photo sensitivity assessments. | percentage of epidermal cells | MEAN |
| SECONDARY | Change in Minimal Erythema Dose (MED) Due to UVB | Day 1 (pre-treatment) to Day 26 | The Per Protocol 1 (PP1) population includes all participants who received any amount of tofacitinib and who completed phototests and skin biopsies at both baseline (Visits 1 and 2) and post-treatment (Visits 4 and 5) time points. Only individuals who completed at least 21 days of IP dosing had the post-treatment phototest. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts. | Day 1 (pre-treatment) to Day 26 | The Per Protocol 1 (PP1) population includes all participants who received any amount of tofacitinib and who completed phototests and skin biopsies at both baseline (Visits 1 and 2) and post-treatment (Visits 4 and 5) time points. Only individuals who completed at least 21 days of IP dosing had the post-treatment phototest. | Count of RNA transcripts | MEAN |
| SECONDARY | Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | Day 0 (pre-treatment) to Day 25 | The Per Protocol 1 (PP1) population includes all participants who received any amount of tofacitinib and who completed phototests and skin biopsies at both baseline (Visits 1 and 2) and post-treatment (Visits 4 and 5) time points. Only individuals who complete at least 21 days of IP dosing had the post-treatment phototest. | CLASI-A Score | MEAN |
| SECONDARY | Change in CLASI Damage Score | Day 0 (pre-treatment) to Day 25 | The Per Protocol 1 (PP1) population includes all participants who received any amount of tofacitinib and who completed phototests and skin biopsies at both baseline (Visits 1 and 2) and post-treatment (Visits 4 and 5) time points. Only individuals who completed at least 21 days of IP dosing had the post-treatment phototest. | CLASI-D Score | MEAN |
| SECONDARY | Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Day 0 (pre-treatment) to Day 25 | The Per Protocol 1 (PP1) population includes all participants who received any amount of tofacitinib and who completed phototests and skin biopsies at both baseline (Visits 1 and 2) and post-treatment (Visits 4 and 5) time points. Only individuals who completed at least 21 days of IP dosing had the post-treatment phototest. | SLEDAI-2K Score | MEAN |
| SECONDARY | Change in Severity Grade for Laboratory Tests From Grade 0 | Screening Visit through Day 40 | The Safety Sample (SS) population includes all participants who received any amount of tofacitinib. | participants | NUMBER |
| SECONDARY | Treatment-emergent Adverse Events by Severity | Day 2 to Day 40 | The Safety Sample (SS) population includes all participants who received any amount of tofacitinib. | Adverse Events | NUMBER |
| SECONDARY | Treatment-emergent Adverse Events by Relationship to Tofacitinib | Day 2 to Day 40 | The Safety Sample (SS) population includes all participants who received any amount of tofacitinib. | Adverse Events | NUMBER |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Tofacitinib | Day 1 | 20.06 | Standard Deviation 9.587 | percentage of epidermal cells |
| Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Tofacitinib | Day 26 | 3.03 | Standard Deviation 2.349 | percentage of epidermal cells |
| Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Tofacitinib | Change from Day 1 to Day 26 | -17.03 | Standard Deviation 8.355 | percentage of epidermal cells |
| Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Tofacitinib | Day 1 | 21.51 | Standard Deviation 12.334 | percentage of epidermal cells |
| Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Tofacitinib | Day 26 | 3.45 | Standard Deviation 2.976 | percentage of epidermal cells |
| Change in Percentage of UVB-induced Apoptotic Epidermal Cells | Tofacitinib | Change from Day 1 to Day 26 | -18.06 | Standard Deviation 11.182 | percentage of epidermal cells |
| Change in Minimal Erythema Dose (MED) Due to UVB | Tofacitinib | +30 mJ/cm2 | 0 | Participants | |
| Change in Minimal Erythema Dose (MED) Due to UVB | Tofacitinib | +20 mJ/cm2 | 0 | Participants | |
| Change in Minimal Erythema Dose (MED) Due to UVB | Tofacitinib | +10 mJ/cm2 | 1 | Participants | |
| Change in Minimal Erythema Dose (MED) Due to UVB | Tofacitinib | Stayed the same | 3 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tofacitinib | 7 | |
| Overall Study | COMPLETED | Tofacitinib | 6 | |
| Overall Study | NOT COMPLETED | Tofacitinib | 1 |
Source ClinicalTrials.gov
Adverse events1
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 | Dental caries | Gastrointestinal disorders | Tofacitinib | 1 | 7 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tofacitinib | 0 | 7 |
| Total, other adverse events | Tofacitinib | 1 | 7 |
| Total, serious adverse events | Tofacitinib | 0 | 7 |
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/NCT05048238
GET https://conductscience.org/api/trials/v1/NCT05048238/results?page=2