ATI-2138 for Eczema

Recruiting at 5 trial locations

Overseen By Laura Connelly

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Aclaris Therapeutics, Inc.

Must not be taking: JAK inhibitors, TYK inhibitors

Disqualifiers: Unstable AD, Refractory AD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

14 Participants Needed

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. ^{1 2 3 4 5}

What 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. ^{5 6 7 8 9}

Is the drug ATI-2138 a promising treatment for eczema?

The provided research articles do not mention ATI-2138, so there is no information available to determine if it is a promising treatment for eczema. ^{3 10 11 12 13}

Research Team

Ajay Aggarwal, MD

Principal Investigator

Aclaris Therapeutics, Inc.

Eligibility 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 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

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

Treatment Details

Interventions

• ATI-2138

Trial Overview 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.

Participant Groups

Group I: ATI-2138 Experimental Treatment 1 Intervention

ATI-2138 oral tablets BID

Who Is Running the Clinical Trial?

Aclaris Therapeutics, Inc.

Lead Sponsor

Trials

35

Recruited

4,900+

Findings from Research

In a study of 88 patients with acute eczema, the treatment group using pricking, blood-letting, and cupping techniques achieved a significantly higher cured and markedly effective rate of 89.1% compared to 42.9% in the control group using conventional medications.

Both groups had similar total effective rates, but the alternative therapy demonstrated a more pronounced effect in curing eczema, suggesting it may be a more effective option for acute cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical observation on pricking and blood-letting and cupping with a three-edge needle for treatment of acute eczema]. Yao, J., Li, NF.[2007]

The Self-Administered EASI (SA-EASI) is a validated tool that allows caregivers to accurately assess the severity of their child's atopic dermatitis, showing strong correlation with the traditional Eczema Area and Severity Index (EASI) scores in a study of 47 caregivers.

This new assessment tool not only enables objective reporting of skin disease severity but also opens the door for older children (over 12 years) to self-assess their condition, potentially enhancing the understanding of eczema's impact on quality of life and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Self-Administered Eczema Area and Severity Index by parent caregivers: results of a validation study. Housman, TS., Patel, MJ., Camacho, F., et al.[2021]

The study established clear interpretability for the Eczema Area and Severity Index (EASI) scores, categorizing them into severity strata that help clinicians and patients understand the severity of atopic dermatitis (AD).

The EASI is user-friendly, taking about 6 minutes for trained investigators to administer, making it a practical tool for both clinical use and research in assessing AD severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Leshem, YA., Hajar, T., Hanifin, JM., et al.[2022]

Oral Janus kinase inhibitors (JAKi) have shown significant clinical efficacy and a reassuring safety profile in treating moderate-to-severe atopic dermatitis, based on a review of 11 studies involving various JAKi agents.

These treatments, including abrocitinib, baricitinib, and upadacitinib, provide rapid symptom control, making them a recommended option for adult patients who do not respond to topical therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review on the Efficacy and Safety of Oral Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis. Le, M., Berman-Rosa, M., Ghazawi, FM., et al.[2021]

Topical Janus Kinase Inhibitors (JAKi), including delgocitinib, tofacitinib, ruxolitinib, cerdulatinib, and ifidancitinib, have been found effective in treating atopic dermatitis (AD) in both adults and children, significantly improving various clinical measures such as EASI and pruritus scores based on a review of 19 studies.

These topical JAKi demonstrated a minimal risk of mild-to-moderate adverse effects, indicating they are safe treatment options for AD, although further long-term studies and direct comparisons are needed to optimize their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topical JAK inhibitors in the treatment of atopic dermatitis in paediatrics and adults: A systematic review. Sadeghi, S., Mohandesi, NA.[2023]

In a review of 18 clinical trials, systemic JAK inhibitors like baricitinib, abrocitinib, and upadacitinib were found to increase the risk of adverse events compared to placebo, indicating a need for careful monitoring of patients.

Abrocitinib and upadacitinib also raised the risk of infections, while dupilumab showed a lower risk of herpes zoster infection compared to upadacitinib, suggesting that while JAK inhibitors are effective, their safety profiles need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and network meta-analysis. Alves, C., Penedones, A., Mendes, D., et al.[2022]

The TREAT Registry Taskforce is launching a long-term safety study to compare the safety of dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema, focusing on the incidence of malignancies and other serious adverse events.

This study will utilize a standardized approach across multiple national registries, providing valuable safety data that can inform regulatory bodies, clinicians, and pharmaceutical companies about the long-term risks associated with these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. Bosma, AL., Spuls, PI., Garcia-Doval, I., et al.[2021]

Oral JAK inhibitors show a moderate safety profile for treating atopic dermatitis, with common side effects including headaches, nausea, and nasopharyngitis, as reported in several reviews and clinical trials.

While JAK inhibitors may have a lower association with some serious adverse effects, there is a potential increased risk for conditions like asthma and neutropenia, and long-term safety data is still limited, though ongoing trials are showing promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations of systemic Janus kinase inhibitors in atopic dermatitis applications. Chang, PH., Huang, SF., Chang, PS., et al.[2021]

Upadacitinib (UPA), a selective JAK-1 inhibitor, has demonstrated safety and efficacy in treating moderate to severe atopic dermatitis based on recent phase 2b and phase 3 clinical trials.

This retrospective study provides insights into the therapeutic response and side effects of UPA therapy specifically in an Australian cohort, highlighting the need for localized data on its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib treatment in patients with moderate to severe atopic dermatitis: A retrospective single-centre Australian review of 14 patients post phase 3 clinical trial. Bennett, M., Sinclair, RD., Eisman, S.[2023]

Atopic eczema (AE) is a complex skin condition influenced by genetic, immunologic, and environmental factors, with two main subtypes that have different implications for disease progression and treatment.

Effective management of AE includes a stepwise approach starting with emollients, followed by moderate topical corticosteroids and immunomodulatory drugs, with proactive treatment strategies shown to reduce flare-ups and overall medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atopic dermatitis - current insights into path physiology and management]. Schmid-Grendelmeier, P., Ballmer-Weber, BK.[2021]

Montelukast, while suggested for treating atopic dermatitis (AD), showed limited efficacy in improving symptoms, with only four out of eleven studies indicating symptom relief, and five studies reporting no significant effects.

The safety profile of montelukast was comparable to that of a placebo, indicating it was well-tolerated with minimal adverse effects, but conventional treatments remain the preferred option until more conclusive evidence is available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the off-label use of montelukast in atopic dermatitis treatment. Chin, WK., Lee, SWH.[2021]

In a cohort study of 15,612 patients, there were 16 reports of improvement in eczema or urticaria after treatment with montelukast, suggesting potential benefits beyond its approved use for asthma.

Out of the 16 cases, 5 were considered by general practitioners to show actual improvement in longstanding eczema or urticaria, indicating that montelukast may have a role in treating these conditions, but further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montelukast and improvement of eczema: observations from a prescription event monitoring study in England. Biswas, P., Wilton, LV., Shakir, SA.[2021]

In a small phase 2 trial involving 10 subjects with moderate to severe atopic dermatitis or allergic contact dermatitis, apremilast was well tolerated with no serious adverse events, but only 20% of participants showed a significant improvement in their condition after 12 weeks.

The efficacy of apremilast in treating atopic dermatitis and allergic contact dermatitis was minimal, with only 10% achieving a 75% reduction in eczema severity, which is lower than its effectiveness reported in psoriasis trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Volf, EM., Au, SC., Dumont, N., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical observation on pricking and blood-letting and cupping with a three-edge needle for treatment of acute eczema]. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Use of the Self-Administered Eczema Area and Severity Index by parent caregivers: results of a validation study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review on the Efficacy and Safety of Oral Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis. [2021]

5. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topical JAK inhibitors in the treatment of atopic dermatitis in paediatrics and adults: A systematic review. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

The safety of systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and network meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. England pubmed.ncbi.nlm.nih.gov

Safety considerations of systemic Janus kinase inhibitors in atopic dermatitis applications. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Atopic dermatitis - current insights into path physiology and management]. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review on the off-label use of montelukast in atopic dermatitis treatment. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Montelukast and improvement of eczema: observations from a prescription event monitoring study in England. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

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]