A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profiles of TLL-018 in Patients With Moderate-to-Severe Atopic Dermatitis

August 21, 2026 updated by: Hangzhou Highlightll Pharmaceutical Co., Ltd

A Phase II/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profiles of TLL-018 in Patients With Moderate-to-Severe Atopic Dermatitis

This is an operationally seamless Phase II/III, multicenter, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe atopic dermatitis (AD). The Phase II stage aims to preliminarily evaluate the efficacy of TLL-018 and identify the dose and sample size for the subsequent Phase III stage, which is designed to confirm the efficacy of TLL-018.

The primary outcome measures are the proportion of participants achieving EASI-75 (≥75% improvement in Eczema Area and Severity Index from baseline) at week 16, and the proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a ≥2-point reduction from baseline at week 16.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang, MD
          • Phone Number: 86-10- 88325472
          • Email: rmzjz@126.com
        • Contact:
          • Cheng Zhou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
TLL-018 10 mg. Dose selection for continuation into Stage 2 (Phase III) will be based on efficacy and safety data generated from Stage 1 (Phase II). This dose group may or may not be carried forward into Stage 2.
Drug: TLL-018 tablets
TLL-018 tablets taken orally 10 mg (1 tablet) twice daily
Drug: TLL-018 tablets
TLL-018 tablets taken orally 20 mg (2 tablets) twice daily
Drug: TLL-018 tablets
TLL-018 tablets taken orally 30 mg (3 tablets) twice daily
Experimental: Arm B
TLL-018 20 mg. Dose selection for continuation into Stage 2 (Phase III) will be based on efficacy and safety data generated from Stage 1 (Phase II). This dose group may or may not be carried forward into Stage 2.
Drug: TLL-018 tablets
TLL-018 tablets taken orally 10 mg (1 tablet) twice daily
Drug: TLL-018 tablets
TLL-018 tablets taken orally 20 mg (2 tablets) twice daily
Drug: TLL-018 tablets
TLL-018 tablets taken orally 30 mg (3 tablets) twice daily
Experimental: Arm C
TLL-018 30 mg. Dose selection for continuation into Stage 2 (Phase III) will be based on efficacy and safety data generated from Stage 1 (Phase II). This dose group may or may not be carried forward into Stage 2.
Drug: TLL-018 tablets
TLL-018 tablets taken orally 10 mg (1 tablet) twice daily
Drug: TLL-018 tablets
TLL-018 tablets taken orally 20 mg (2 tablets) twice daily
Drug: TLL-018 tablets
TLL-018 tablets taken orally 30 mg (3 tablets) twice daily
Placebo Comparator: Arm D
Placebo. This arm will be used in both Stage 1 (Phase II) and Stage 2 (Phase III).
Drug: Placebo
Placebo taken orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of trial participants achieving at least 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) at Week 16
Time Frame: Week 16
The Eczema Area and Severity Index (EASI) is a validated, physician-assessed tool used to measure the extent and severity of atopic dermatitis (eczema). The total score ranges from 0 to 72, with higher scores indicating more severe disease.
Week 16
Proportion of trial participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 with a reduction of ≥ 2 points at Week 16
Time Frame: Week 16

The Investigator's Global Assessment (IGA) is a physician-reported, static measure used to rate the overall severity of atopic dermatitis at a given time point.

It typically uses a 5-point scale from 0 to 4: 0 = Clear, 4 = Severe.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Highlightll Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

August 21, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLL-018-305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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