Atopic Dermatitis (AD)Phase 2/3NCT07784816
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profiles of TLL-018 in Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 2/3 study testing TLL-018 tablets in people with Atopic Dermatitis (AD), run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- TLL-018 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 30 Sep 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Liver function: AST or ALT > 2 × upper-limit-of-normal (ULN); total bilirubin > 2 × ULN.
- Serum creatinine ≥ 1.2 × ULN.
- Coagulation: PT or APTT > ULN with clinical significance.
- 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.
- 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:
- History of active TB without documented clinical cure.
- Screening imaging (e.g., chest-CT) demonstrating active TB.
- Suspicious TB-related symptoms that cannot be ruled out by investigator (low-grade fever, cough, night-sweats, weight loss etc.).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, 100044
Jianzhong Zhang, MD, 86-10- 88325472, rmzjz@126.com
Cheng Zhou, MD
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- TLL-018 tablets, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL-018 tabletsDrug
TLL-018 tablets taken orally 10 mg (1 tablet) twice daily
TLL-018 tabletsDrug
TLL-018 tablets taken orally 20 mg (2 tablets) twice daily
TLL-018 tabletsDrug
TLL-018 tablets taken orally 30 mg (3 tablets) twice daily
PlaceboDrug
Placebo taken orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784816
- Sponsor's protocol ID
- TLL-018-305
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07784816
- Acronym / sponsor ID
- TLL-018-305
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: TLL-018 tabletsTLL-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. |
| Arm B | Experimental | Drug: TLL-018 tabletsTLL-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. |
| Arm C | Experimental | Drug: TLL-018 tabletsTLL-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. |
| Arm D | Placebo comparator | Drug: PlaceboPlacebo. This arm will be used in both Stage 1 (Phase II) and Stage 2 (Phase III). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (27 listed)
- Presence of any of the following diseases or medical histories:
- Any screening laboratory abnormality meeting the following thresholds:
- Tuberculosis-related exclusion criteria:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLL-018 tabletsTLL-018 tablets taken orally 10 mg (1 tablet) twice daily | Drug | Arm A |
| TLL-018 tabletsTLL-018 tablets taken orally 20 mg (2 tablets) twice daily | Drug | Arm B |
| TLL-018 tabletsTLL-018 tablets taken orally 30 mg (3 tablets) twice daily | Drug | Arm C |
| PlaceboPlacebo taken orally twice daily | Drug | Arm D |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TLL-018 tablets in people with Atopic Dermatitis (AD), run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.