Trial Outcomes & Findings for A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata (NCT NCT02684097)
NCT ID: NCT02684097
Last Updated: 2020-01-07
Results Overview
Change from baseline in cellular, and molecular markers in skin biopsies after treatment. Gene expression changes in Th2/IL-13, "T22"/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A jointly correlated assessed as change at week 24 compared to baseline of the biomarkers combined z-score expression. Th2/IL-13, T22/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A biomarkers was computed as following. The combined score was obtained by mean z-score expression of all biomarkers, where z-score normalized expression of biomarker X and sample i was obtained by the following formula: \[Xi - mean(Xall\_samples)\]/sd(Xall\_samples). Change in combined z-score for each patient was calculated from two time points as the value at the later time point minus the value at the earlier time point.
COMPLETED
PHASE2
22 participants
Baseline and Week 24
2020-01-07
Participant Flow
Participant milestones
| Measure |
Tralokinumab
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
7
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
| Measure |
Tralokinumab
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
13
|
6
|
Baseline Characteristics
A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata
Baseline characteristics by cohort
| Measure |
Tralokinumab
n=15 Participants
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
n=7 Participants
Saline subcutaneous injection every two weeks for 24 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.67 years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
47.57 years
STANDARD_DEVIATION 16.37 • n=7 Participants
|
44.23 years
STANDARD_DEVIATION 13.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Severity of Alopecia Tool (SALT)
|
80.92 units on a scale
STANDARD_DEVIATION 25.65 • n=5 Participants
|
72.25 units on a scale
STANDARD_DEVIATION 25.51 • n=7 Participants
|
78.16 units on a scale
STANDARD_DEVIATION 25.33 • n=5 Participants
|
|
Alopecia Areata Symptom Impact Scale (AASIS)
|
54.67 units on a scale
STANDARD_DEVIATION 28.04 • n=5 Participants
|
51.57 units on a scale
STANDARD_DEVIATION 21.19 • n=7 Participants
|
53.68 units on a scale
STANDARD_DEVIATION 25.59 • n=5 Participants
|
|
Alopecia Areata Quality of Life (AA-QoL)
|
51.07 units on a scale
STANDARD_DEVIATION 12.98 • n=5 Participants
|
51.57 units on a scale
STANDARD_DEVIATION 7.82 • n=7 Participants
|
51.23 units on a scale
STANDARD_DEVIATION 11.39 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: data only for those participants who had a biopsy. No participants in placebo group had a biopsy.
Change from baseline in cellular, and molecular markers in skin biopsies after treatment. Gene expression changes in Th2/IL-13, "T22"/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A jointly correlated assessed as change at week 24 compared to baseline of the biomarkers combined z-score expression. Th2/IL-13, T22/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A biomarkers was computed as following. The combined score was obtained by mean z-score expression of all biomarkers, where z-score normalized expression of biomarker X and sample i was obtained by the following formula: \[Xi - mean(Xall\_samples)\]/sd(Xall\_samples). Change in combined z-score for each patient was calculated from two time points as the value at the later time point minus the value at the earlier time point.
Outcome measures
| Measure |
Tralokinumab
n=2 Participants
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Change in Gene Expression Th2/IL-13, "T22"/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A Jointly Correlated
|
-0.28 z-score
Standard Deviation 1.61
|
—
|
SECONDARY outcome
Timeframe: Week 24Percentage change from Baseline in the Severity of Alopecia Tool (SALT) at Week 24. SALT score 0-100 with lower score indicating better health outcomes.
Outcome measures
| Measure |
Tralokinumab
n=2 Participants
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
n=1 Participants
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Percentage Change From Baseline in the Severity of Alopecia Tool (SALT)
|
0.49 percentage change
Standard Deviation 33.75
|
0 percentage change
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Number of patients achieving 50% or greater improvement in their SALT score (SALT50) at Week 24, compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.
Outcome measures
| Measure |
Tralokinumab
n=2 Participants
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
n=1 Participants
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Number of Patients Achieving 50% or Greater Improvement in Their SALT Score (SALT50)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Percentage change from baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 24. AASIS score 0-130 with lower score indicating better health outcomes.
Outcome measures
| Measure |
Tralokinumab
n=2 Participants
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
n=1 Participants
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Percentage Change From Baseline in the Alopecia Areata Symptom Impact Scale (AASIS)
baseline
|
64 percent change
Standard Deviation 35.36
|
69 percent change
Standard Deviation 0
|
|
Percentage Change From Baseline in the Alopecia Areata Symptom Impact Scale (AASIS)
week 24
|
57 percent change
Standard Deviation 52.33
|
50 percent change
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Percentage change from Baseline in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Week 24. AA-QoL score 0-100 with higher score indicating better health outcomes.
Outcome measures
| Measure |
Tralokinumab
n=2 Participants
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
n=1 Participants
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Percentage Change From Baseline in the Alopecia Areata Quality of Life Questionnaire (AA-QoL)
baseline
|
59 percentage change
Standard Deviation 14.14
|
47 percentage change
Standard Deviation 0
|
|
Percentage Change From Baseline in the Alopecia Areata Quality of Life Questionnaire (AA-QoL)
week 24
|
58 percentage change
Standard Deviation 22.63
|
35 percentage change
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 40Side effects to study the safety of tralokinumab in patients with moderate to severe alopecia areata and in patients with concomitant moderate to severe alopecia areata and atopic dermatitis
Outcome measures
| Measure |
Tralokinumab
n=15 Participants
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
n=7 Participants
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Number of Adverse Events
|
8 events
|
3 events
|
Adverse Events
Tralokinumab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tralokinumab
n=15 participants at risk
Tralokinumab subcutaneous injection every two weeks for 24 weeks
|
Placebo
n=7 participants at risk
Saline subcutaneous injection every two weeks for 24 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
20.0%
3/15 • 40 weeks
|
14.3%
1/7 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection (URI)
|
20.0%
3/15 • 40 weeks
|
14.3%
1/7 • 40 weeks
|
|
Cardiac disorders
Hypertensive Urgency
|
0.00%
0/15 • 40 weeks
|
14.3%
1/7 • 40 weeks
|
|
Eye disorders
Corneal Abrasion
|
6.7%
1/15 • 40 weeks
|
0.00%
0/7 • 40 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
6.7%
1/15 • 40 weeks
|
0.00%
0/7 • 40 weeks
|
Additional Information
Dr. Emma Guttman
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place