ifidancitinib (ATI-502) / Aclaris, Rigel - LARVOL DELTA

Protocol for a systematic review and meta-analysis on Janus kinase inhibitors in the management of vitiligo. (PubMed, Syst Rev) - "The proposed systematic review and meta-analysis describe the methods for summarizing and synthesizing the evidence on the effectiveness and patient-centered outcomes concerning the treatment of vitiligo with JAK inhibitors that were recently approved for this indication. To disseminate further the results of our systematic review, we plan to present them at international conferences and meetings. Our findings will provide robust evidence to facilitate decision-making at the policy or practitioner level."

Journal • Retrospective data • Review • Dermatology • Immunology • Vitiligo

Alopecia areata: What's new in the diagnosis and treatment with JAK inhibitors? (PubMed, J Dermatol) - "This review focuses on the evaluation, diagnosis, and treatment of AA. We also provide the latest information on the safety and efficacy of JAK inhibitors for the treatment of AA and describe their mechanisms of action."

Journal • Review • Alopecia • Dermatology • Immunology

Which is the Ideal JAK Inhibitor for Alopecia Areata - Baricitinib, Tofacitinib, Ritlecitinib or Ifidancitinib - Revisiting the Immunomechanisms of the JAK Pathway. (PubMed, Indian Dermatol Online J) - "Moreover, the response achieved with JAKibs is not sustained after treatment discontinuation, with many studies showing a high recurrence rate with tofacitinib and ruxolitinib post-treatment...Thus, JAK3ibs may be associated with a better side effect profile and, in conjunction with their specificity, may replace other JAKibs as the treatment of choice for AA. We herein discuss the role of the JAK/STAT (signal transducer and activator of transcription) pathway in AA, the intricacies of various JAKibs in the management of AA, and emphasize the need for studies on tissue JAK and cytokine expression before arriving at the ideal JAKibs for AA."

Journal • Review • Alopecia • IFNG • JAK3

Assessment of clinical studies registered across trial registries for Alopecia Areata (EADV-Sp 2023) - "Deuruxolitinib, ritlecitinib, tofacitinib, ivarmacitinib, and ifidancitinib were among the most common drugs being tested in the Phase 3/Phase 4 trials. Most trials were placebo-controlled trials and the others had comparators such as minoxidil (5%), tacrolimus (0.1%), and clobetasol propionate...The study shows the focus on JAK inhibitors as an upcoming treatment modality. There is a need for generation of real world evidence on upcoming treatment modalities."

Clinical • Alopecia • Immunology

Efficacy and Safety of Topical JAK inhibitors in the Treatment of Atopic Dermatitis in Pediatrics and Adults: A Systematic Review. (PubMed, Exp Dermatol) - "Available topical JAKi are effective and safe modalities in treating AD. Nevertheless, further studies with longer duration and head-to-head comparative trials are necessary to find the best option with the least adverse effects."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pediatrics • Pruritus

Induction of T cell exhaustion by JAK1/3 inhibition in the treatment of alopecia areata. (PubMed, Front Immunol) - "Ifidancitinib is a potent and selective next-generation JAK1/3 inhibitor predicted to disrupt γc cytokine signaling...Furthermore, we found that γc cytokines regulated T cell exhaustion. Taken together, our data indicate that selective induction of T cell exhaustion using a JAK inhibitor may offer a mechanistic explanation for the success of this treatment strategy in the reversal of autoimmune diseases such as AA."

IO biomarker • Journal • Alopecia • Immune Modulation • Immunology • Inflammation • CD8 • IFNG • JAK1

A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution (clinicaltrials.gov) - P2; N=31; Completed; Sponsor: Aclaris Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Alopecia

A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo (clinicaltrials.gov) - P2; N=34; Completed; Sponsor: Aclaris Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dermatology • Vitiligo

A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata (clinicaltrials.gov) - P2; N=129; Terminated; Sponsor: Aclaris Therapeutics, Inc.; Active, not recruiting ➔ Terminated; The double-blind primary endpoint was not met. Open Label Extension period halted as a result.

Clinical • Trial termination • Alopecia • Dermatopathology

ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT) (clinicaltrials.gov) - P2; N=56; Terminated; Sponsor: Aclaris Therapeutics, Inc.; N=80 ➔ 56; Trial completion date: Jan 2020 ➔ Aug 2019; Active, not recruiting ➔ Terminated; Sponsor Decision

Enrollment change • Trial completion date • Trial termination

Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT) (clinicaltrials.gov) - P2; N=11; Completed; Sponsor: Aclaris Therapeutics, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ Jun 2019; Trial primary completion date: Dec 2019 ➔ Jun 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata (clinicaltrials.gov) - P2; N=128; Active, not recruiting; Sponsor: Aclaris Therapeutics, Inc.; Trial completion date: Jan 2020 ➔ Sep 2019

Clinical • Trial completion date

ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT) (clinicaltrials.gov) - P2; N=80; Active, not recruiting; Sponsor: Aclaris Therapeutics, Inc.; Enrolling by invitation ➔ Active, not recruiting

Clinical • Enrollment closed

JAK inhibitor yields hair growth in women: Top dermatology stories from last week (Healio) - "In other big news from last week, approximately half of patients with vitiligo treated with ruxolitinib cream achieved a 50% improvement in facial Vitiligo Area Severity Index scores at week 24, meeting the primary endpoint in a phase 2 study. David Rosmarin, MD, primary investigator of the study, explained the study results an interview....ATI-502, an investigational topical JAK 1/3 inhibitor, was evaluated in adult women and men with androgenetic alopecia and applied to the scalp twice daily for 26 weeks....Approximately half of patients with vitiligo treated with ruxolitinib cream achieved a 50% improvement in facial Vitiligo Area Severity Index scores at week 24, meeting the primary endpoint in a phase 2 study, David Rosmarin, MD, primary investigator of the study, told Healio Dermatology."

Media quote

A Study of ATI-502 Topical Solution for the Treatment of Atopic Dermatitis (clinicaltrials.gov) - P2; N=22; Completed; Sponsor: Aclaris Therapeutics, Inc.; Recruiting ➔ Completed

Clinical • Trial completion

ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT) (clinicaltrials.gov) - P2; N=80; Enrolling by invitation; Sponsor: Aclaris Therapeutics, Inc.; Not yet recruiting ➔ Enrolling by invitation

Clinical • Enrollment open

Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT) (clinicaltrials.gov) - P2; N=12; Active, not recruiting; Sponsor: Aclaris Therapeutics, Inc.; Trial primary completion date: Jan 2019 ➔ Dec 2019

Clinical • Trial primary completion date

A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata (clinicaltrials.gov) - P2; N=128; Active, not recruiting; Sponsor: Aclaris Therapeutics, Inc.; Trial completion date: Jan 2019 ➔ Jan 2020; Trial primary completion date: Jan 2019 ➔ May 2019

Clinical • Trial completion date • Trial primary completion date

JAK inhibitors offer hope for vitiligo patients (DermatologyTimes) - "Other researchers led by Dr. King have also observed that patients whose vitiligo improved with tofacitinib did so on areas of exposed skin. 'So he hypothesized that this was due to exposure to light. Whether it's sunlight or visible light, it's hard to know. But exposed skin seems to do better with JAK inhibitors, suggesting that light was also beneficial in promoting the reversal of disease.'"

Media quote

A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution (clinicaltrials.gov) - P2; N=31; Active, not recruiting; Sponsor: Aclaris Therapeutics, Inc.; Trial completion date: Oct 2018 ➔ Oct 2019; Trial primary completion date: Oct 2018 ➔ Oct 2019

Clinical • Trial completion date • Trial primary completion date

A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo (clinicaltrials.gov) - P2; N=34; Active, not recruiting; Sponsor: Aclaris Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; N=24 ➔ 34; Trial completion date: Nov 2018 ➔ Sep 2019; Trial primary completion date: Nov 2018 ➔ Sep 2019

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Open Label Study of ATI-50002 Topical Solution Administered to Adult Subjects With Eyebrow Loss Due to Alopecia Areata (clinicaltrials.gov) - P2; N=1; Completed; Sponsor: Aclaris Therapeutics, Inc.; Recruiting ➔ Completed; N=12 ➔ 1

Clinical • Enrollment change • Trial completion