Trial Outcomes & Findings for Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus (NCT NCT05048238)
NCT ID: NCT05048238
Last Updated: 2025-08-22
Results Overview
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.
COMPLETED
PHASE1
7 participants
Day 1 (pre-treatment) to Day 26
2025-08-22
Participant Flow
Two study sites were activated in the United States, beginning in March 2022. A total of eight participants were screened from September 2022 to January 2024 at both sites. Of those screened seven participants enrolled in the study.
Participant milestones
| Measure |
Tofacitinib
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tofacitinib
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
Baseline characteristics by cohort
| Measure |
Tofacitinib
n=7 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 6.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Diagnosed with Systemic Lupus Erythematosus (SLE)
Yes
|
3 Participants
n=5 Participants
|
|
Diagnosed with Systemic Lupus Erythematosus (SLE)
No
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Scale
Type I
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Scale
Type II
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Scale
Type III
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Scale
Type IV
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Scale
Type V
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Scale
Type VI
|
0 Participants
n=5 Participants
|
|
SLEDAI-2K Score (Clinical Criteria Only)
|
0.9 SLEDAI-2K Score
STANDARD_DEVIATION 1.07 • n=5 Participants
|
|
CLASI Total Activity (CLASI-A) Score
|
2.4 CLASI-A Score
STANDARD_DEVIATION 3.87 • n=5 Participants
|
|
CLASI Total Damage (CLASI-D) Score
|
2.9 CLASI-D Score
STANDARD_DEVIATION 5.40 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-treatment) to Day 26Population: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=6 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in Percentage of UVB-induced Apoptotic Epidermal Cells
Day 1
|
20.06 percentage of epidermal cells
Standard Deviation 9.587
|
|
Change in Percentage of UVB-induced Apoptotic Epidermal Cells
Day 26
|
3.03 percentage of epidermal cells
Standard Deviation 2.349
|
|
Change in Percentage of UVB-induced Apoptotic Epidermal Cells
Change from Day 1 to Day 26
|
-17.03 percentage of epidermal cells
Standard Deviation 8.355
|
PRIMARY outcome
Timeframe: Day 1 (pre-treatment) to Day 26Population: The Per Protocol 2 (PP2) population includes all PP1 participants with no protocol deviations that would impact photo sensitivity assessments.
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.
Outcome measures
| Measure |
Tofacitinib
n=3 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in Percentage of UVB-induced Apoptotic Epidermal Cells
Day 1
|
21.51 percentage of epidermal cells
Standard Deviation 12.334
|
|
Change in Percentage of UVB-induced Apoptotic Epidermal Cells
Day 26
|
3.45 percentage of epidermal cells
Standard Deviation 2.976
|
|
Change in Percentage of UVB-induced Apoptotic Epidermal Cells
Change from Day 1 to Day 26
|
-18.06 percentage of epidermal cells
Standard Deviation 11.182
|
SECONDARY outcome
Timeframe: Day 1 (pre-treatment) to Day 26Population: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=6 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in Minimal Erythema Dose (MED) Due to UVB
+30 mJ/cm2
|
0 Participants
|
|
Change in Minimal Erythema Dose (MED) Due to UVB
+20 mJ/cm2
|
0 Participants
|
|
Change in Minimal Erythema Dose (MED) Due to UVB
+10 mJ/cm2
|
1 Participants
|
|
Change in Minimal Erythema Dose (MED) Due to UVB
Stayed the same
|
3 Participants
|
|
Change in Minimal Erythema Dose (MED) Due to UVB
-10 mJ/cm2
|
0 Participants
|
|
Change in Minimal Erythema Dose (MED) Due to UVB
-20 mJ/cm2
|
1 Participants
|
|
Change in Minimal Erythema Dose (MED) Due to UVB
-30 mJ/cm2
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-treatment) to Day 26Population: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=6 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
TNF at Day 1
|
-5.5 Count of RNA transcripts
Standard Deviation 10.13
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
TNF at Day 26
|
-0.8 Count of RNA transcripts
Standard Deviation 5.85
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
TNF Change from Day 1 to Day 26
|
4.7 Count of RNA transcripts
Standard Deviation 6.50
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IL1B at Day 1
|
38.5 Count of RNA transcripts
Standard Deviation 42.57
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IL1B at Day 26
|
4.8 Count of RNA transcripts
Standard Deviation 20.82
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IL1B Change from Day 1 to Day 26
|
-33.7 Count of RNA transcripts
Standard Deviation 44.85
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
CXCL9 at Day 1
|
53.8 Count of RNA transcripts
Standard Deviation 63.35
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
CXCL9 at Day 26
|
133.7 Count of RNA transcripts
Standard Deviation 246.27
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
CXCL9 Change from Day 1 to Day 26
|
79.8 Count of RNA transcripts
Standard Deviation 289.29
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IL6 at Day 1
|
-0.7 Count of RNA transcripts
Standard Deviation 5.24
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IL6 at Day 26
|
10.5 Count of RNA transcripts
Standard Deviation 25.74
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IL6 Change from Day 1 to Day 26
|
11.2 Count of RNA transcripts
Standard Deviation 25.33
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IFNB1 at Day 1
|
0.0 Count of RNA transcripts
Standard Deviation 0.00
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IFNB1 at Day 26
|
0.00 Count of RNA transcripts
Standard Deviation 0.00
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IFNB1 Change from Day 1 to Day 26
|
0.0 Count of RNA transcripts
Standard Deviation 0.00
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IFI44 at Day 1
|
10.2 Count of RNA transcripts
Standard Deviation 54.62
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IFI44 at Day 26
|
109.5 Count of RNA transcripts
Standard Deviation 137.50
|
|
Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.
IFI44 Change from Day 1 to Day 26
|
99.3 Count of RNA transcripts
Standard Deviation 107.08
|
SECONDARY outcome
Timeframe: Day 0 (pre-treatment) to Day 25Population: 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 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.
Outcome measures
| Measure |
Tofacitinib
n=6 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
Day 0
|
2.8 CLASI-A Score
Standard Deviation 4.07
|
|
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
Day 25
|
2.3 CLASI-A Score
Standard Deviation 3.27
|
|
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
Change from Day 0 to Day 25
|
-0.5 CLASI-A Score
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Day 0 (pre-treatment) to Day 25Population: 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 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.
Outcome measures
| Measure |
Tofacitinib
n=6 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in CLASI Damage Score
Day 0
|
3.3 CLASI-D Score
Standard Deviation 5.75
|
|
Change in CLASI Damage Score
Day 25
|
2.8 CLASI-D Score
Standard Deviation 4.67
|
|
Change in CLASI Damage Score
Change to Day 25
|
-0.5 CLASI-D Score
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Day 0 (pre-treatment) to Day 25Population: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=6 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Day 0
|
1.3 SLEDAI-2K Score
Standard Deviation 1.63
|
|
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Day 25
|
1.7 SLEDAI-2K Score
Standard Deviation 1.97
|
|
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change to Day 25
|
0.3 SLEDAI-2K Score
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Screening Visit through Day 40Population: The Safety Sample (SS) population includes all participants who received any amount of tofacitinib.
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.
Outcome measures
| Measure |
Tofacitinib
n=7 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Change in Severity Grade for Laboratory Tests From Grade 0
Alanine Aminotransferase: Increase by 1 grade
|
1 participants
|
|
Change in Severity Grade for Laboratory Tests From Grade 0
Alanine Aminotransferase: Increase by 2+ grades
|
0 participants
|
|
Change in Severity Grade for Laboratory Tests From Grade 0
Aspartate Aminotransferase: Increase by 1 grade
|
1 participants
|
|
Change in Severity Grade for Laboratory Tests From Grade 0
Aspartate Aminotransferase: Increase by 2+ grades
|
0 participants
|
|
Change in Severity Grade for Laboratory Tests From Grade 0
Total Cholesterol: Increase by 1 grade
|
2 participants
|
|
Change in Severity Grade for Laboratory Tests From Grade 0
Total Cholesterol: Increase by 2+ grades
|
0 participants
|
SECONDARY outcome
Timeframe: Day 2 to Day 40Population: The Safety Sample (SS) population includes all participants who received any amount of tofacitinib.
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.
Outcome measures
| Measure |
Tofacitinib
n=7 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Treatment-emergent Adverse Events by Severity
Grade 2
|
1 Adverse Events
|
|
Treatment-emergent Adverse Events by Severity
Grade 3
|
0 Adverse Events
|
|
Treatment-emergent Adverse Events by Severity
Grade 4
|
0 Adverse Events
|
|
Treatment-emergent Adverse Events by Severity
Grade 5
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: Day 2 to Day 40Population: The Safety Sample (SS) population includes all participants who received any amount of tofacitinib.
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.
Outcome measures
| Measure |
Tofacitinib
n=7 Participants
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Treatment-emergent Adverse Events by Relationship to Tofacitinib
Related to Tofacitinib
|
0 Adverse Events
|
|
Treatment-emergent Adverse Events by Relationship to Tofacitinib
Not Related to Tofacitinib
|
1 Adverse Events
|
Adverse Events
Tofacitinib
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tofacitinib
n=7 participants at risk
25-day regimen of tofacitinib 11 mg daily
|
|---|---|
|
Gastrointestinal disorders
Dental caries
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events were collected in EDC from Day 2 until Day 40.
Adverse events (AEs) of Grade 2 or higher and all Grade 1 or higher COVID-19 events were recorded in EDC. 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.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place