Aclaris Reports Strong Phase 2a Results for ATI-2138 in Atopic Dermatitis

Aclaris Reports Strong Phase 2a Results for ATI-2138 in Atopic Dermatitis

By, Admin 5 August 2025

Aclaris Therapeutics Inc., a clinical-stage biopharma innovator targeting immuno-inflammatory diseases, has announced promising topline results from its Phase 2a trial of ATI-2138.

This open-label, single-arm study evaluated the investigational oral therapy in 14 patients with moderate-to-severe atopic dermatitis (AD).

What Makes ATI-2138 Stand Out?

  • Dual Inhibitor: ATI-2138 targets both ITK and JAK3, offering a novel mechanism for immune modulation.
  • Low Dose, High Impact: Patients were treated with 10 mg BID for 12 weeks, showing clinically meaningful results.
  • No Serious Adverse Events: Safety profile was clean—no SAEs or significant lab abnormalities.

Key Outcomes from the Trial

1. Confirmed Safety and Tolerability

  • No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) were reported.
  • Only four treatment-related adverse events (TRAEs) were observed across three patients—all were mild or moderate and resolved during treatment.

2. Clinically Meaningful Efficacy

  • EASI Scores: Significant reductions in the Eczema Area and Severity Index.
  • Itch Reduction: Multiple patients achieved ≥4-point improvement in worst itch (PP-NRS).
  • Comparability: Results suggest comparable or better efficacy than approved JAK or IL-4/13 inhibitors, even at this low dose.

Why This Matters for Future Indications

The success of this trial validates Aclaris’ broader ITK-focused drug development strategy.

“We accomplished our goals: confirm tolerability, test the mechanism in AD, and validate ITK as a therapeutic target,”

  • Dr. Neal Walker, CEO, Aclaris.

Given the strong results, Aclaris plans to advance ATI-2138 in alopecia areata, with potential to expand into vitiligo and other Th2/Th1/Th17-mediated diseases.

Leading Experts Weigh In

“The PD data are compelling. We saw strong downregulation of Th2, Th1/Th17, and fibrosis markers,”

  • Dr. Emma Guttman, Professor of Dermatology & Immunology, Mount Sinai.

She emphasized the potential of ITK inhibition as a therapeutic strategy for autoimmune and atopic disorders.

About ATI-2138

Mechanism of Action:

  • Inhibits ITK (regulator of T-cell receptor signaling)
  • Inhibits JAK3 (partner to JAK1 in IL-2 receptor signaling)

Therapeutic Potential:

  • Supports T cell modulation without the safety risks of broader JAK inhibition
  • Demonstrated efficacy in animal models and healthy human SAD/MAD trials

What’s Next?

Aclaris plans to:

  • Advance ATI-2138 into larger clinical trials for alopecia areata
  • Explore additional autoimmune and inflammatory conditions linked to T-cell and IL-2Rγc signaling

Final Takeaway

ATI-2138 could redefine the treatment paradigm for atopic dermatitis and T-cell driven autoimmune diseases. Aclaris has cleared a major hurdle—now the real momentum begins.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!