NCT02684097

A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata

A Randomized Placebo-controlled Single Center Pilot Study of the Safety and Efficacy of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Emma Guttman · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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. Expected is 50% of these subjects to have concomitant alopecia areata (AA) and atopic dermatitis (AD). Subjects with AA alone (15 subjects) will be randomized (2:1) to either receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks. Subjects with concomitant alopecia areata and atopic dermatitis (15 subjects) will be randomized separately in a 2:1 ratio to receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks.

Detailed description

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Tralokinumab	All groups will receive study drug every two weeks for 24 weeks.
DRUG	Placebo	Matching placebo given every two weeks for 24 weeks

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-11-28
• Completion: 2017-11-28
• First posted: 2016-02-17
• Last updated: 2020-01-07
• Results posted: 2020-01-07

Locations

1 site across 1 country: United States