A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Tralokinumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All groups will receive study drug every two weeks for 24 weeks.; Matching placebo given every two weeks for 24 weeks
Other intervention name(s): Saline subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alopecia, Alopecia Totalis, Alopecia Universalis