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

NCT07784816 | Not Yet Recruiting Phase 2

• 1 other identifier: TLL-018-305
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (2)

• Proportion of trial participants achieving at least 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) at 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

  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

Study Arms (4)

Arm A

EXPERIMENTAL

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

Arm B

EXPERIMENTAL

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

Arm C

EXPERIMENTAL

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

Arm D

PLACEBO COMPARATOR

Placebo. This arm will be used in both Stage 1 (Phase II) and Stage 2 (Phase III).

Drug: Placebo

Interventions

TLL-018 tablets DRUG

TLL-018 tablets taken orally 10 mg (1 tablet) twice daily

Arm A

Placebo DRUG

Placebo taken orally twice daily

Arm D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• Presence of any of the following diseases or medical histories:
• 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.
• Concurrent active inflammatory skin diseases that may confound efficacy assessment.
• Current or prior lymphoproliferative disorders, or suggestive signs/symptoms including lymphadenopathy or splenomegaly.
• 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.
• Herpes zoster within 1 year before randomization; any prior disseminated or recurrent herpes zoster; any prior disseminated herpes simplex.
• 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.
• Acquired or hereditary immunodeficiency disorders.
• Severe haematological diseases, or conditions predisposing to haemolysis or red-cell instability.
• Documented psychiatric disorders likely to impair trial compliance, or known poor adherence.
• Major surgery or severe trauma within 4 weeks pre-randomization, or planned major surgery during the trial.
• Prior or planned solid-organ transplantation (e.g., liver transplantation).
• History or evidence of high-risk cardiovascular/cerebrovascular disease.
• Any screening laboratory abnormality meeting the following thresholds:
• 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.

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

CN (1)