Can a daily pill tame severe eczema?
NCT ID NCT07784816
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This clinical trial is testing an oral medication called TLL-018 in adults with moderate-to-severe atopic dermatitis, a chronic skin condition causing itchy, inflamed skin. The study aims to see if TLL-018 can significantly improve skin symptoms compared to a placebo. Participants will take the drug or placebo twice daily for several weeks, and researchers will measure changes in eczema severity using standard skin assessments. The trial is designed to evaluate both the effectiveness and safety of this potential new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TLL-018 tablets taken by mouth
- What this could lead to
- If successful, TLL-018 could offer a new oral treatment option for people with moderate-to-severe atopic dermatitis, potentially reducing symptoms and improving quality of life.
- What could go wrong
- This is an early-stage trial, so the drug may not prove more effective than placebo. Possible side effects are not yet fully known, and results may not apply to all patients.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 390 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
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: * The trial participant understands and voluntarily signs the informed consent form (ICF), and has the willingness and ability to complete the scheduled follow-up visits, treatment plans, laboratory tests, and other trial procedures required by the protocol. * Male or female trial participants aged ≥18 and ≤75 years at the time of signing the ICF. * Have a history of atopic dermatitis for at least 1 year at screening, and meet the Hanifin-Rajka diagnostic criteria. * At screening and randomization, meet the criteria for moderate-to-severe atopic dermatitis as assessed by the investigator, with all of the following 4 conditions met simultaneously: Eczema Area and Severity Index (EASI) ≥16; Investigator's Global Assessment (IGA) ≥3; Body Surface Area (BSA) affected by atopic dermatitis ≥10%; Weekly average of Worst Itch Numeric Rating Scale (WI-NRS) ≥4. 5\. In the investigator's judgment, have received topical treatment for atopic dermatitis within 6 months prior to screening with inadequate clinical response or intolerance, or require systemic therapy to control the disease. 6\. The trial participant is able and willing to regularly use a mild emollient without active ingredients twice daily for at least 7 consecutive days prior to randomization, and to continue using it throughout the study. 7\. Female trial participants of childbearing potential must not be pregnant or lactating, and may enter the study only after pregnancy test results are confirmed negative. 8\. Female trial participants of childbearing potential, male trial participants, and their partners must use adequate and effective contraceptive measures from the screening period until 90 days after the last dose, and must have no plans to donate sperm (males) or ova (females) from the screening period until at least 6 months after the last dose. Exclusion Criteria: * Presence of any of the following diseases or medical histories: 1. Inability to swallow investigational product, refractory nausea/vomiting, malabsorption, external biliary diversion; history of gastrointestinal perforation (excluding perforation secondary to appendicitis or mechanical trauma); gastrointestinal disorders impairing drug absorption or other malabsorption conditions. 2. Concurrent active inflammatory skin diseases that may confound efficacy assessment. 3. Current or prior lymphoproliferative disorders, or suggestive signs/symptoms including lymphadenopathy or splenomegaly. 4. History of malignancy prior to screening, except for treated-and-cured non-melanoma skin cancer/basal-cell carcinoma, cervical carcinoma in-situ, or breast ductal carcinoma in-situ. 5. Herpes zoster within 1 year before randomization; any prior disseminated or recurrent herpes zoster; any prior disseminated herpes simplex. 6. Severe/systemic infections within 4 weeks pre-randomization requiring intravenous anti-infective therapy or resulting in infection-related hospitalization; or other active/recent infections judged by the investigator to confer unacceptable subject risk. 7. Acquired or hereditary immunodeficiency disorders. 8. Severe haematological diseases, or conditions predisposing to haemolysis or red-cell instability. 9. Documented psychiatric disorders likely to impair trial compliance, or known poor adherence. 10. Major surgery or severe trauma within 4 weeks pre-randomization, or planned major surgery during the trial. 11. Prior or planned solid-organ transplantation (e.g., liver transplantation). 12. History or evidence of high-risk cardiovascular/cerebrovascular disease. * Any screening laboratory abnormality meeting the following thresholds: 1. Complete blood count: haemoglobin \< 90 g/L; white-blood-cell count \< 2.5 × 10⁹/L; absolute-neutrophil count \< 1.5 × 10⁹/L; lymphocyte count \< 0.8 × 10⁹/L; platelet count \< 100 × 10⁹/L. 2. Liver function: AST or ALT \> 2 × upper-limit-of-normal (ULN); total bilirubin \> 2 × ULN. 3. Serum creatinine ≥ 1.2 × ULN. 4. Coagulation: PT or APTT \> ULN with clinical significance. 5. Uncontrolled hypertension: SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg. Confirmatory measurement: if initial reading exceeds threshold, rest ≥ 5 minutes then re-measure once; use repeat value if below threshold. 6. Uncontrolled dyslipidaemia: fasting total cholesterol ≥ 7.2 mmol/L, or fasting LDL-C ≥ 4.9 mmol/L, or fasting triglycerides \> 5.6 mmol/L. * Tuberculosis-related exclusion criteria: 1. History of active TB without documented clinical cure. 2. Screening imaging (e.g., chest-CT) demonstrating active TB. 3. Suspicious TB-related symptoms that cannot be ruled out by investigator (low-grade fever, cough, night-sweats, weight loss etc.). 4. Latent tuberculosis infection (LTBI): positive TB assay (T-SPOT-TB, QuantiFERON-TB-Gold etc.) without active-TB signs/symptoms. * Progressive/uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric or cerebral disease; investigator judges participation poses unacceptable risk. * Known or suspected hypersensitivity to TLL-018 active substance, excipients, or agents of the same drug class.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University People's Hospital
Beijing, 100044, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase 2 randomized, double-blind, Placebo-Controlled, Parallel-Group, Multi-Center study to evaluate the safety and efficacy of PRA-216 in participants with moderate to severe atopic dermatitis
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