Clinical Trial Explores Antibody Tralokinumab for Alopecia Areata

A clinical trial being run by the Icahn School of Medicine at New York's Mount Sinai hospital is set to investigate whether the drug tralokinumab could also prove effective for autoimmune-related hair loss.

Researchers are currently recruiting thirty participants with moderate Alopecia Areata through to severe Alopecia Universalis - autoimmune conditions which cause bald patches on the scalp or complete baldness, respectively - to take part in these Phase 2 trials.

Exploring autoimmune connections

According to the clinical trial registration, the basis for this trial comes from the researchers' past experience of the skin condition psoriasis - another autoimmune disorder.

It is common for people with autoimmune conditions to have more than one; there are, in fact, a number of conditions that people with Alopecia Areata have been found to be more susceptible to, including Type 1 Diabetes and Dry Eye Disease. Therefore, exploring the connections between different autoimmune conditions and how they respond to certain treatments could be beneficial across the board.

The documentation for this new study states that previous psoriasis research '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.'

In light of this, the explanation that this particular trial is designed as more of an information-gathering mission 'designed to gain basic knowledge rather than to yield information directly related to patient care', makes sense. As such, participants' results will not be added to their medical records although this can happen at a later date if any test results or situations relating to the patients' health warrant this action being taken.

Links between alopecia areata and atopic dermatitis

This study will use a randomised, double-blind method with placebo controls to assess the potential of tralokinumab for treating various stages of alopecia areata involving 30-100% of the scalp. The research team also state that they expect 50 per cent of the trial participants to have both concomitant alopecia areata (AA) and atopic dermatitis (AD), also known as eczema.

An Example of Atopic Dermatitis

Studies have shown AD to be another autoimmune condition; it is generally a long-term, chronic condition that causes inflammation of the skin making it appear flaky and cracked with an itching sensation. It presents mostly in children but can also affect adults and is believed to have a genetic link as it can run in families.

Interlukein 13, or IL-13, is a protein found in humans and mice, and effects the body's immune cells. According to the Icahn School team, '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.' Being able to establish genome profiling alongside molecular and cellular markers will help researchers compare how IL-13 can effect the pathways associated with Alopecia Areata and those associated with Atopic Dermatitis.

The trial is due to complete its primary findings in October 2017 and we will report on the outcome as soon as results are published. For now, however, there are effective Alopecia Areata treatment options for people with patchy scalp hair loss. Belgravia's specialists have achieved significant regrowth results for many clients with this condition through tailoring bespoke treatment plans to their specific needs, based around topical applications of suitable high strength minoxidil formulations available from our clinic's pharmacies.