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Phase 2a Alopecia Areata Treatment Trial For Ruxolitinib Analogue

After decades of apparent silence, the race to develop safe and effective hair loss treatment options for people affected by severe autoimmune alopecia is really hotting up.

There has been an exciting stream of significant developments regarding the potential treatment of forms of alopecia areata using janus kinase inhibition from top researchers at Columbia University in the States. Now, fellow US-based Concert Pharmaceuticals Inc has announced its latest clinical trial into an ‘analogue’ form of the JAK inhibitor ruxolitinib.

Diagram Belgravia Centre Different Types of Alopecia Areata autoimmune hair lossTreating autoimmune alopecia

Alopecia Areata is an autoimmune disorder which causes a malfunction of the hair growth cycle. It can affect men, women and children and tends to present suddenly. Though the precise reason the body suspends normal hair production is unknown, a number of triggers have been identified. These include sudden shock, trauma, allergies and a genetic element is also suspected.

There are various degrees to which alopecia can present and each is categorised into a different phenotype. The most moderate of these is Alopecia Areata – confusingly, the same term which is given to the group of autoimmune hair loss conditions – and it causes sudden, patchy bald spots to the scalp only. More drastic is Alopecia Totalis, which causes baldness of the head, meaning no hair on the scalp or facial hair, including a lack of eyelashes and eyebrows. Most extreme is Alopecia Universalis which causes all the hair from head to toe to be shed. There are also further variations including one which can affect solely beard hair, and another which presents as a bald ring around the hairline.

Though professional Alopecia Areata treatment can be extremely successful in cases where the bald areas are confined solely to the scalp, the harsher phenotypes currently have no truly significant treatment options.

For the past few years, there has looked to be light appearing at the end of the tunnel for those who have never had realistic hair regrowth choices before. These have almost exclusively focused on the use of janus kinase inhibitor drugs (JAK inhibitors) to regrow hair in confirmed, and often long-term cases of both Alopecia Totalis and Alopecia Universalis.

One of the first JAK inhibitor drugs to be investigated as a potential severe alopecia areata treatment was something called ruxolitinib. Available under the brand name Jakafi, this drug is currently only available to be used in the treatment of patients with certain blood disorders. It is, however, being developed as an option for those with autoimmune hair loss and the latest information confirmed that a phase 2a clinical trial is exploring a version of ruxolitinib known as CTP-543.

Investigating CTP-543 for hair regrowth

Concert Pharmaceuticals announced via a press release that enrollment for the first part of its Phase 2a trial is now complete. This part of the study will involve testing CTP-543 via sequential dosing in order to evaluate the safety and efficacy of the drug in relation to treating moderate to severe forms of alopecia areata.

Ruxolitinib (Brand Name: Jakafi)

The new drug being tested is based on Ruxolitinib

CTP-543 is a ‘deuterium-modified analog’ of ruxolitinib; an ‘analog’ drug – or ‘analogue’ to those of us in the UK – is one which closely resembles another in structure. In this instance, Concert used its deuterium chemistry technology to modify its Jakafi ruxolitinib drug to produce CTP-543.

The trial involves 90 adults with various severities of alopecia, from scalp-only alopecia areata through to alopecia universalis and is broken down into two parts.

Firstly, the group will each be randomly assigned a dose of either 4 mg of CTP-543 or a placebo, which they will take twice a day for 24 weeks. The results will be analysed for safety issues by an independent data monitoring company at the end of this period. They will then make recommendations for the second part of the trial based on their findings.

It is estimated that this will be completed by the end of the first quarter of 2018, after which the second part of the trial will commence. This involves volunteers being randomly assigned a twice-daily drug of either 4mg of CTP-543 or 8mg of CTP-543, to be taken as instructed for a 24 week period.

“The primary outcome measure will utilize the severity of alopecia tool (SALT) after 24 weeks of dosing. Patient-reported outcome measures will be assessed as secondary endpoints. If appropriate, the protocol may be amended to explore higher doses of CTP-543…” states the Concert-released press information. Adding, “CTP-543 has been well-tolerated in clinical evaluation to date and has demonstrated a non-clinical safety profile consistent with therapeutic JAK inhibition.”

Assuming everything goes to plan, the results from the latter part of this clinical trial should be released in late 2018 or early 2019.

Although the MHRA and FDA have not approved any drugs for the treatment of alopecia areata, Belgravia has found that by using a custom plan featuring recommended formulations of high strength minoxidil, – people with the scalp-only moderate form of alopecia areata can see significant results. Minoxidil is the only clinically-proven and MHRA and FDA approved unisex hair loss treatment for androgenetic alopecia (female and male pattern baldness). However, this drug is only suitable for those over 16 years of age and – as before – only has the potential to be effective in cases of patchy hair loss on the scalp.

Whilst there are none available yet, the possibility of there potentially being a fully-authorised, safe and effective alopecia totalis and alopecia universalis treatment option available within the next few years is hugely exciting, and one we are keeping a close eye on.


Belgravia Centre Hair Loss Clinic Reception - New StreetThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.


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