A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata
|ClinicalTrials.gov Identifier: NCT02684097|
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alopecia Areata||Drug: Tralokinumab Drug: Placebo||Phase 2|
The purpose of this study is to assess whether tralokinumab can be a helpful treatment for alopecia areata.
This is a randomized, double-blind, placebo-controlled pilot study of a total of 30 subjects with moderate to severe alopecia areata involving 30-100% of the scalp. The researchers expect 50% of these subjects to have concomitant alopecia areata (AA) and atopic dermatitis (AD).
The researchers' experience in AD12-14, and past experience in psoriasis15, 16 showed that biomarker studies in skin tissues are critical to the understanding of key pathogenic pathways that are upregulated in each disease and how well they are suppressed with effective treatment. These mechanistic studies coupled with clinical trials are key in the disease to shed light on important disease mechanisms, and to explain which molecules are suppressed by each therapeutic target. Data shows that IL-13 is significantly upregulated in both AD and AA lesions compared to nonlesional skin. It is very important to associate the clinical responses with suppression of this cytokine and related molecules as well as other pathway cytokines in skin tissues. Both the whole genomic profiling and individual molecular and cellular markers are very important in order to understand how well anti-IL-13 will change/suppress AA-associated pathways and compare with those that will be suppressed in AD.
Since this study is designed to gain basic knowledge rather than to yield information directly related to patient care, the results are not entered in the participants' medical records. If, at a later date, correlations of in-vitro tests and the patients' clinical situation suggest that the results do bear on the patients' health, an amended protocol will be submitted to the IRB so that results can be made available to the medical record.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Placebo-controlled Single Center Pilot Study of the Safety and Efficacy of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||November 28, 2017|
|Actual Study Completion Date :||November 28, 2017|
Active Comparator: Tralokinumab
Tralokinumab subcutaneous injection every two weeks for 24 weeks
All groups will receive study drug every two weeks for 24 weeks.
Placebo Comparator: Placebo
Saline subcutaneous injection every two weeks for 24 weeks.
Matching placebo given every two weeks for 24 weeks
Other Name: Saline subcutaneous injection
- Gene expression changes in Th2/IL-13, "T22"/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A jointly correlated [ Time Frame: Week 24 ]Change from baseline in cellular, and molecular markers in skin biopsies after treatment
- Severity of Alopecia Tool (SALT) [ Time Frame: Baseline and Week 24 ]Percentage change from Baseline in the Severity of Alopecia Tool (SALT) at Week 24.
- SALT score (SALT50) [ Time Frame: Baseline and Week 24 ]Percentage of patients achieving 50% or greater improvement in their SALT score (SALT50) at Week 24, compared to Baseline.
- Alopecia Areata Symptom Impact Scale (AASIS) [ Time Frame: Baseline and Week 24 ]Percentage change from baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 24.
- Alopecia Areata Quality of Life questionnaire (AA-QoL) [ Time Frame: Baseline and Week 24 ]Percentage change from Baseline in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Week 24
- Side effects [ Time Frame: Week 40 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684097
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Emma Guttman, MD, PhD||ISMMS|