ATI-2138 for Eczema
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Aclaris Therapeutics, Inc.
Must not be taking: JAK inhibitors, TYK inhibitors
Disqualifiers: Unstable AD, Refractory AD, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have used systemic JAK or TYK inhibitors before, you cannot participate.
What data supports the idea that ATI-2138 for Eczema is an effective treatment?
The available research does not provide specific data on ATI-2138 for Eczema. However, it discusses the effectiveness of Janus Kinase Inhibitors (JAKi), a class of drugs that ATI-2138 might belong to, in treating eczema. Studies show that JAKi can quickly reduce symptoms and are safe for moderate-to-severe eczema when other treatments don't work. This suggests that ATI-2138 could be effective if it shares similar properties with other JAKi drugs.
12345What safety data is available for ATI-2138 in treating eczema?
The safety data for ATI-2138, a Janus kinase (JAK) inhibitor, in treating eczema is limited. However, studies on similar JAK inhibitors suggest a moderate safety profile. Common adverse effects include headaches, nausea, nasopharyngitis, acne, herpes simplex, herpes zoster, and eczema herpeticum. There is also a potential risk for asthma, acute pancreatitis, neutropenia, and thrombocytopenia. While long-term safety data is limited, ongoing clinical trials show promising preliminary results.
56789Eligibility Criteria
This trial is for adults aged 18-60 with a history of moderate to severe atopic dermatitis (AD) or eczema for at least one year. Participants should not have had significant AD flares in the month before screening and must be able to understand and sign consent forms. Pregnant or nursing women, those planning pregnancy during the study, or anyone who has used certain systemic inhibitors are excluded.Inclusion Criteria
Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures
I am between 18 and 60 years old, not pregnant, and not nursing.
I have had moderate or severe atopic dermatitis for over a year with no severe flares in the last month.
Exclusion Criteria
I have never taken JAK or TYK inhibitors before.
I am not pregnant, nursing, or planning to become pregnant during the study.
Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive ATI-2138 oral tablets BID for 12 weeks to assess safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing ATI-2138, an investigational drug for treating moderate to severe atopic dermatitis. It's a Phase 2 trial where all participants receive ATI-2138 openly without being compared to another treatment or placebo.
1Treatment groups
Experimental Treatment
Group I: ATI-2138Experimental Treatment1 Intervention
ATI-2138 oral tablets BID
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Aclaris Investigational SiteEncino, CA
Aclaris Investigational SiteSan Diego, CA
Aclaris Investigational SiteSan Antonio, TX
Aclaris Investigational SiteAustin, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Aclaris Therapeutics, Inc.Lead Sponsor
References
[Clinical observation on pricking and blood-letting and cupping with a three-edge needle for treatment of acute eczema]. [2007]To search for an effective therapy for acute eczema.
Use of the Self-Administered Eczema Area and Severity Index by parent caregivers: results of a validation study. [2021]The Eczema Area and Severity Index (EASI) is used by dermatological investigators world-wide to assess eczema disease severity. EASI measures are, however, time-consuming and require trained personnel, thereby limiting its application to large-scale epidemiological studies. Additionally, the use of self-assessed severity indices in dermatology is restricted to adult subjects and conditions, thereby not addressing the needs of paediatric patients.
What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. [2022]The Eczema Area and Severity Index (EASI) is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis (AD). The EASI was identified as one of the best-validated outcome measures for AD; however, no previous studies address how to interpret the EASI score for clinical use.
Systematic Review on the Efficacy and Safety of Oral Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis. [2021]Background: Atopic dermatitis is a chronic, relapsing and remitting disease that can be difficult to treat despite a recently approved biologic therapy targeting IL-4/IL-13 receptor. Oral janus kinase inhibitors (JAKi) represent a novel therapeutic class of targeted therapy to treat moderate-to-severe atopic dermatitis (AD). Objective: To review the efficacy, safety, and pharmacokinetic characteristics of oral JAKi in the treatment of AD. Methods: A PRISMA systematic review was conducted using MEDLINE, EMBASE (Ovid), and PubMed databases for studies assessing the efficacy, safety, and/or pharmacokinetic properties of oral forms of JAKi in the treatment of AD in pediatric or adult populations from inception to June 2021. Results: 496 papers were reviewed. Of 28 articles that underwent full text screening, 11 met our inclusion criteria for final qualitative review. Four studies examined abrocitinib; three studies examined baricitinib; three examined upadacitinib and one examined gusacitinib (ASN002). Significant clinical efficacy and a reassuring safety profile was reported for all JAKi agents reviewed. Rapid symptom control was reported for abrocitinib, baricitinib and upadacitinib. Limitations: Given the relatively limited evidence for each JAKi and the differences in patient eligibility criteria between studies, the data was not deemed suitable for a meta-analysis at this time. Conclusion: Given their ability to achieve rapid symptom control with a reassuring safety profile, we recommend considering the use of JAKi as a reliable systemic treatment option for adult patients with moderate-to-severe AD, who are unresponsive to topical or skin directed treatments.
Efficacy and safety of topical JAK inhibitors in the treatment of atopic dermatitis in paediatrics and adults: A systematic review. [2023]Atopic dermatitis (AD) is the most common skin inflammatory disease. Dysregulation of innate and adaptive immune systems plays a major role in the pathophysiology of AD. JAKi (Janus Kinase Inhibitors) reduce the production of pro-inflammatory cytokines and represent a promising novel treatment for AD. To assess and summarize the overall efficacy and safety of topial JAKi in the treatment of AD in adults and pediatrics, a broad search was performed on Ovid Medline, Ovid Embase, Cochrane Library, Web of Sciences, Scopus, CINAHL and Google Scholar until 14 June 2022. After screening, 19 studies remained for the final review. The current systematic review was conducted according to PRISMA, and the protocol was registered in PROSPERO (ID #CRD42022303321). Topical delgocitinib, tofacitinib, ruxolitinib, cerdulatinib and ifidancitinib are effective in treating AD and significantly improve EASI, IGA, pruritus-NRS score and some other indexes in adults. Moreover, topical delgocitinib was observed to have a great efficacy in the treatment of AD in paediatrics. All topical JAKi showed minimal risk of mild-to-moderate adverse effects. 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.
The safety of systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and network meta-analysis. [2022]Janus kinase (JAK) inhibitors have been developed to treat moderate to severe atopic dermatitis, but there is little evidence comparing the safety profile of these drugs. The aim of this study is to compare the relative safety of the different systemic JAK inhibitors in atopic dermatitis.
TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. [2021]A long-term prospective observational safety study is essential to characterize fully the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset.
Safety considerations of systemic Janus kinase inhibitors in atopic dermatitis applications. [2021]Janus kinase (JAK) inhibitors are emerging treatments for atopic dermatitis (AD). Due to this novel role as a therapeutic option for patients with AD, we aimed to review current evidence on the pathophysiology and the safety and adverse effects (AEs) of oral JAK inhibitors for the treatment of AD utilizing the key terms atopic dermatitis, JAK inhibitors, and adverse effect or event. Our study indicated that oral JAK inhibitors have a moderate safety profile for use in AD in several reviews and phase II or III clinical trials. Headaches, nausea, and nasopharyngitis are the most commonly reported systemic AEs. Furthermore, acne, herpes simplex, herpes zoster, and eczema herpeticum are the most commonly recorded dermatological AEs. Current evidence indicates JAK inhibitors may also have less association with some of the serious AEs, although there is potential for increased risk of asthma, acute pancreatitis, neutropenia, and thrombocytopenia. Whereas data remain limited for the long-term safety of JAK inhibitor use in patients with AD, many ongoing clinical trials have promising preliminary results.
Upadacitinib treatment in patients with moderate to severe atopic dermatitis: A retrospective single-centre Australian review of 14 patients post phase 3 clinical trial. [2023]Recent phase 2b and phase 3 clinical trials support the safety and efficacy of the selective Janus kinase (JAK)-1 inhibitor upadacitinib (UPA) in the treatment of moderate to severe atopic dermatitis (AD). However, to date, there is little experience with UPA therapy for AD in Australia. We report findings from a retrospective study to better understand the therapeutic response and side effects noted in a single-centre Australian cohort.
[Atopic dermatitis - current insights into path physiology and management]. [2021]Atopic eczema (AE) is a multifaktoriell skin disease caused by a variety of factors such as genetic conditions, alterated skin structure, immunologic deviations, psychological and environmental factors, among others. There are two main subtypes of AE, i.e. the IgE-associated ("extrinsic atopic eczema") and the non-IgE-associated type ("intrinsic atopic eczema") with different prognosis concerning the development of respiratory diseases ("atopy march"). The role of allergens varies: while in early childhood food allergens may play a role, mites and microbial antigens may become more relevant in adolescence and adulthood. Recently, it was demonstrated that Filaggrin is a major gene for atopic eczema. The altered skin structure and a deficiency in antimicrobial peptides favour colonization with Staphylococcus aureus; their enterotoxins with superantigenic activity stimulate activation of T cells and macrophages. Also sensitization to the yeast Malassezia spp. occurs almost exclusively in AE patients. So far, AE skin lesions are orchestrated by the local tissue expression of proinflammatory cytokines and chemokines with activation of T lymphocytes, dendritic cells, macrophages, keratinocytes, mast cells, and eosinophils which lead to the skin inflammatory responses. From the therapeutic point of view, a step wise approach using emollients as a basic treatment is recommended. Modern topical corticosteroids of moderate to medium potency applied once per day and only on several days per week offer an efficient anti-inflammatory treatment with moderate side effects. Topic immunomodulatory drugs (tacrolimus and pimecrolimus) have in addition substantially improved the treatment of AE. Proactive treatment approaches also in disease-free intervals may reduce exacerbations and total drug use. Phototherapy and wet dressings are both efficient and safe additional tools in more severe forms. For generalized severe forms systemic drugs such as Cyclosporin A are very helpful. Various Biologicals and antipruriginous substances are under clinical investigation and may add to an improved therapy in the future.
A systematic review on the off-label use of montelukast in atopic dermatitis treatment. [2021]Background Atopic dermatitis (AD) is the most common form of eczema. As leukotriene mediators are involved in the inflammatory phase of atopic dermatitis, montelukast has been suggested as a possible therapy. Aim of the review To evaluate the safety and efficacy of montelukast off-label use for the treatment atopic dermatitis. Method A search was performed from database inception until March 2018 in six electronic databases for randomized-controlled-trials examining the use of montelukast for AD. Results Among 301 articles screened, 11 studies met the inclusion criteria and were included in the review. The study populations consist of paediatric and adult subjects with moderate-to-severe AD. Montelukast use was shown to improve symptoms such as pruritus in four studies. Another 2 studies reported that montelukast could improve symptoms similar to the standard regimen of topical steroid and oral antihistamine. However, five studies reported that montelukast had no effects in symptoms alleviation. The use of montelukast was associated with a similar safety profile to placebo and well-tolerated with minimal adverse effects. Conclusion There is limited evidence to suggest that the off-label use of montelukast is effective in treating moderate-to-severe AD. Further research with larger study populations employing standardized endpoint measuring instrument is warranted to further investigate the off-label use of montelukast in AD treatment. Until then, the use of conventional treatments including optimal daily skin hydration should remain the mainstay in the management of atopic dermatitis. In fact, for moderate-to-severe condition, steroid sparing immune-suppressants should still be used clinically until more effective and safer alternative is discovered.
Montelukast and improvement of eczema: observations from a prescription event monitoring study in England. [2021]Montelukast is an orally administered cysteinyl receptor antagonist, approved for the treatment of asthma. There is pharmacological plausibility of its effectiveness in the treatment of other immunologically mediated conditions such as eczema and urticaria. The objective of this study was to determine whether there are any beneficial effects of montelukast on eczema and urticaria.
A phase 2, open-label, investigator-initiated study to evaluate the safety and efficacy of apremilast in subjects with recalcitrant allergic contact or atopic dermatitis. [2022]Evaluate the efficacy and safety of apremilast, a novel phosphodiesterase 4 (PDE4) inhibitor, in subjects with recalcitrant moderate to severe atopic dermatitis (AD) or allergic contact dermatitis (ACD).