New pill could soothe severe eczema without creams
NCT ID NCT06996912
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an experimental oral drug called HSK44459 in 150 adults with moderate-to-severe atopic dermatitis (eczema). Participants take the drug or a placebo twice daily for 12 weeks. The goal is to see if the drug safely reduces skin redness, swelling, and itch better than a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK44459
- What this could lead to
- If successful, this could lead to a new oral treatment option for moderate-to-severe atopic dermatitis, helping reduce skin inflammation and itching.
- What could go wrong
- This is an early Phase 2 trial with only 150 participants, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
-
Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Written informed consent must be obtained * Male or female, ≥18 years old and ≤75 years old * Willing and able to comply with study-specific procedures and the requirements of this study protocol. * Atopic dermatitis has been present for at least 1 year and subject meets Hanifin and Rajka criteria * EASI score≥16 at the screening and baseline visits * IGA score≥3 at the screening and baseline visits * ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits * Baseline WI-NRS≥4 * History of inadequate response to TCS of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]) or systemic treatment for AD within 6 months prior to screening * Have applied a stable dose of topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit Exclusion Criteria: * Subjects have used AD treatments within the time frame specified in protocol prior to the baseline visit * Prior exposure to any PDE4 inhibitor systemic treatment * Systemic use of known strong CYP3A inhibitors or strong CYP3A inducers within 4 weeks or 5 half-lives prior to randomization or during the course of the study * Participation in other clinical studies within 4 weeks or 5 half-lives prior to randomization * Subjects have laboratory values meeting the criteria in protocol * Presence of skin comorbidities that may interfere with study assessments * Concurrent conditions and history of other diseases as described in protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, 250022, China
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