Chronic Spontaneous Urticaria (CSU)Phase 1/2NCT07665996
A Phase Ib/IIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 Antihistamines
A Phase 1/2 study testing TLL-018 in people with Chronic Spontaneous Urticaria (CSU), run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria (CSU)
- What is being tested?
- TLL-018
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 31 Dec 2027
- Phase
- Phase 1/2
- 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
- Aged between 18 and 75.
- Diagnosis of CSU refractory to second-generation H1-AH.
- CSU diagnosis for ≥ 6 months.
- The presence of itch and hives despite current use of an approved dose of H1-AH for ≥ 6 weeks prior to screening visit.
- UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (ISS range 0-21) ≥ 8 during 7 days prior to randomization (Day 1), and ISS ≥2 on the day of randomization.
- Participants are required to take a stable standard dose of a second generation H1-AH concomitantly according to local guidelines.
Show all 9Show fewer
- Willing and able to to comply with the study protocol and complete the participant diary throughout the study period. Participants shall have no more than one missing urticaria symptom score (morning or evening HSS score and ISS score) within 7 days prior to randomization, and no missing HSS score or ISS score on the day immediately before randomization..
- Women of Child Bearing Potential (WOCBP) should not be pregnant or breastfeeding and the pregnancy test should be negative before randomization.
- Participants (whether male or female) should have adequate barrier contraception during the whole treatment period and at least 90 days after treatment; subjects should avoid the sperm or ovum donation for at least six months after treatment.
Who cannot join
- Participants who meet the diagnostic criteria for chronic spontaneous urticaria (CSU) shall be excluded if they present with any of the following conditions:
- Progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric or cerebral disorders that, in the investigator's judgment, would expose the patient to unacceptable risk from study participation.
- A well-defined underlying etiology of chronic urticaria other than CSU, such as inducible urticaria, including but not limited to dermatographism, cold contact urticaria, heat contact urticaria, delayed pressure urticaria, solar urticaria, vibratory angioedema, cholinergic urticaria, aquagenic urticaria, and contact urticaria.
- Other diseases presenting with urticaria or angioedema symptoms, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, drug-induced urticaria, and hereditary or acquired angioedema.
- Other chronic pruritic diseases that may interfere with efficacy outcome assessment, such as psoriasis, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, and senile pruritus.
- History of any malignant neoplasm prior to screening, with the exception of non-melanoma skin cancer (NMSC) or basal cell carcinoma that has been adequately treated and deemed cured, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.
Show all 38Show fewer
- History of lymphoproliferative disorders (including but not limited to Epstein-Barr virus-related lymphoproliferative disorders, lymphoma, leukemia, etc.); or signs or symptoms suggestive of active lymphoproliferative disorder.
- History of cardiovascular or cerebrovascular events or related surgical procedures within 12 months prior to screening, including but not limited to myocardial infarction, unstable angina pectoris, acute coronary syndrome, cerebral hemorrhage, stroke, coronary artery stent implantation, percutaneous transluminal coronary angioplasty, and coronary artery bypass graft surgery.
- History of thromboembolic events within 12 months prior to screening (e.g., pulmonary thromboembolism, deep vein thrombosis, mesenteric artery embolism); or current high-risk factors for thromboembolic diseases (e.g., immobilization within 12 weeks prior to screening, congenital or hereditary thrombophilia, antiphospholipid antibody syndrome, etc.).
- History of gastrointestinal perforation, except for cases caused by appendicitis or trauma.
- History of herpes zoster within 1 year prior to randomization; history of disseminated herpes zoster or recurrent herpes zoster at any time prior to randomization; history of disseminated herpes simplex at any time prior to randomization.
- Positive HBsAg prior to randomization (or negative HBsAg with positive HBcAb and abnormal HBV-DNA test results), positive HCV antibody (with abnormal HCV-RNA test results), positive HIV antibody, or positive syphilis serological antibody; or known HIV infection or known immunodeficiency status.
- Any severe or systemic infection (bacterial, fungal, viral, parasitic, etc.) requiring intravenous antimicrobial therapy or resulting in hospitalization within 4 weeks prior to randomization; or any other active or recent infection that, in the investigator's judgment, would expose the participating patient to unacceptable risk.
- Tuberculosis-related exclusion: Medical history, symptoms and relevant test results (e.g., tuberculosis screening test, chest X-ray) at screening suggest active tuberculosis.
- History of severe hematologic disorders (e.g., aplastic anemia, myelodysplastic syndrome) or any disease that may cause hemolysis or erythrocyte instability, such as malaria and hemolytic anemia.
- Participants with any of the following prior therapies or concomitant medications cannot be enrolled:
- Receipt of treatment with JAK inhibitors (e.g., tofacitinib, baricitinib, ruxolitinib, etc.) or BTK inhibitors (e.g., remibrutinib) within 4 weeks prior to randomization.
- Receipt of any investigational medicinal product within 4 weeks or 5 elimination half-lives prior to randomization, whichever is longer.
- Prior exposure to omalizumab or omalizumab biosimilars.
- Use of biologic agents with potential therapeutic effect on chronic spontaneous urticaria (CSU) (e.g., dupilumab, GR1802, SYB507, etc.) within 3 months or 5 elimination half-lives prior to randomization, whichever is longer.
- Receipt of immunosuppressive or immunomodulatory agents within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, ciclosporin, Tripterygium wilfordii tablets, Tripterygium glycosides tablets, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, dapsone, sulfasalazine and hydroxychloroquine.
- Receipt of Traditional Chinese Medicine (TCM) or Chinese patent medicine explicitly indicated for urticaria per the package insert, clinical practice guidelines or prescription, within 4 weeks prior to randomization.
- Receipt of topical therapy or phototherapy for CSU within 2 weeks prior to randomization.
- Underwent major surgery within 4 weeks prior to randomization, or is scheduled to undergo major surgery after study enrollment.
- Received any live vaccine within 2 months prior to screening, or plans to receive any live vaccine during the study period.
- Donated a total of ≥400 mL of blood, or received blood transfusion, within 3 months prior to randomization.
- History of drug or alcohol abuse within 6 months prior to screening (defined as 14 units of alcohol per week; 1 unit = 17.7 mL of pure ethanol, equivalent to 357 mL of 5% ABV beer, 43 mL of 40% ABV liquor, or 147 mL of 12% ABV wine).
- History of allergy to any component of the investigational medicinal product or H1-antihistamines, or history of anaphylactic shock.
- Abnormal findings at screening that meet any of the following criteria:
- Complete blood count (CBC): hemoglobin (Hb) < 90 g/L; or white blood cell (WBC) count < 2.5 × 10⁹/L; or absolute neutrophil count (ANC) < 1.5 × 10⁹/L; or absolute lymphocyte count (ALC) < 0.8 × 10⁹/L; or platelet (PLT) count < 100 × 10⁹/L.
- Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN), or total bilirubin (TBIL) > 2 × ULN.
- nSerum creatinine ≥ 1.2 × ULN.
- Coagulation function: either prothrombin time (PT) or activated partial thromboplastin time (APTT) exceeds the ULN and is clinically significant.
- Uncontrolled hypertension (systolic blood pressure [SBP] ≥ 160 mmHg and/or diastolic blood pressure [DBP] ≥ 100 mmHg). One repeat measurement shall be performed for confirmation: if the initial blood pressure reading exceeds the above threshold, a repeat test will be conducted after the participant has rested for at least 10 minutes; if the repeat result is below the threshold, the second measurement value shall be adopted.
- Uncontrolled hyperlipidemia (fasting total cholesterol ≥ 7.2 mmol/L, or fasting low-density lipoprotein cholesterol [LDL-C] ≥ 4.9 mmol/L, or fasting triglycerides [TG] > 5.6 mmol/L).
- Abnormal cardiac function, or clinically significant abnormal electrocardiogram (ECG) findings that are assessed by the investigator to pose unpredictable risks, such as severe arrhythmia.
- Other abnormal examination findings that, in the investigator's judgment, may impair the participant's ability to complete the study or interfere with study outcomes.
- Any other condition or circumstance that, in the investigator's judgment, renders the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Clinical Trial Assessing the Rapid Onset Characteristics of TLL-018 in Subjects With Moderate-to-Severe Chronic Spontaneous Urticaria Who Fail to Achieve Adequate Control With Second-Generation H1 Antihistamines
The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.
The main objectives are:
To evaluate the rapid onset characteristics of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.
To evaluate the safety profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.
To evaluate the pharmacokinetic (PK) profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.
Participants will be randomly allocated at a 1:1:1 ratio to receive TLL-018 10 mg, TLL-018 20 mg, or placebo orally after meals.
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Being tested
- TLL-018, Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL-018Drug
Participants will receive TLL-018 10 mg (1 tablet) and placebo (1 tablet) orally after meals, with a dosing interval of 12 hours (±15 minutes)
TLL-018Drug
Participants will receive TLL-018 20 mg (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes)
PlaceboDrug
Participants will receive placebo (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | TLL-018 10 mg Receives: Drug: TLL-018; Drug: Placebo |
| Arm 2 | Experimental | TLL-018 20 mg Receives: Drug: TLL-018 |
| Arm 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first achievement of ≥1-point reduction from baseline in in-clinic Itch Severity Scale after first dose
Time from first dose until the first clinic assessment where a ≥1-point reduction from baseline in Itch Severity Scale (ISS, range 0-3; higher = worse itch) at in-clinic evaluation.
Measured: First dose up to day 2
Time to first ≥1-point reduction from baseline in in-clinic Hive Severity Scale after first dose
Time from first dose to the first in-clinic assessment with ≥1-point reduction from baseline on Hive Severity Scale (HSS, 0-3).
Measured: First dose up to day 2
Change from baseline in in-clinic Itch Severity Scale post first dose
Mean change from baseline of in-clinic ISS (0-3) at scheduled timepoints after first dose.
Measured: First dose up to 8 hours post first dose
Change from baseline in in-clinic Hive Severity Scale post first dose
Mean change from baseline of in-clinic Hive Severity Scale (0-3) at scheduled timepoints after first dosing.
Measured: First dose up to 8 hours post first dose
Change from baseline in in-clinic Numeric Rating Scale post first dose
Mean change from baseline of in-clinic Numeric Rating Scale (clinic NRS, 0-10) at scheduled timepoints after first dosing.
Measured: First dose up to 8 hours post first dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale post first dose
Percentage of participants achieving ≥1-point reduction from baseline on in-clinic Itch Severity Scale (0-3) at each in-clinic timepoint post first dose.
Measured: First dose up to 8 hours post first dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale post first dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Measured: First dose up to 8 hours post first dose
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale post first dose (baseline clinic Numeric Rating Scale ≥3)
Percentage of participants with baseline NRS score ≥3 who attain ≥3-point reduction from baseline on NRS (0-10) at each in-clinic assessment after first dose.
Measured: First dose up to 8 hours post first dose
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale post first dose (baseline clinic Numeric Rating Scale ≥4)
Percentage of participants with baseline Numeric Rating Scale score ≥4 who attain ≥4-point reduction from baseline on NRS (0-10) at each in-clinic assessment after first dose.
Measured: First dose up to 8 hours post first dose
Change from baseline in Itch Severity Scale at Day 0.5, Day 1, Day 1.5 post first dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Measured: First dose up to 1.5 days post first dose
Change from baseline in Hive Severity Scale at Day 0.5, Day 1, Day 1.5 post first dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Measured: First dose up to 1.5 days post first dose
Change from baseline in Worst Itch Numeric Rating Scale at Day 0.5, Day 1, Day 1.5 post first dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Measured: First dose up to 1.5 days post first dose
Change from baseline in in-clinic Itch Severity Scale at 2 hours post second dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Measured: 2 hours post second dose
Change from baseline in in-clinic Hive Severity Scale at 2 hours post second dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Measured: 2 hours post second dose
Change from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Measured: 2 hours post second dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale at 2 hours post second dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Measured: 2 hours post second dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale at 2 hours post second dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Measured: 2 hours post second dose
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose (baseline clinic Numeric Rating Scale ≥3)
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Measured: 2 hours post second dose
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose (baseline clinic Numeric Rating Scale ≥4)
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Measured: 2 hours post second dose
Secondary outcomes (7)
Change from baseline in in-clinic Itch Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Measured: Within 1 hour prior to third dose to 2 hours post third dose
Change from baseline in in-clinic Hive Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Measured: Within 1 hour prior to third dose to 2 hours post third dose
Change from baseline in in-clinic Numeric Rating Scale within 1 hour prior to third dose and at 2 hours post third dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Measured: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Measured: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Measured: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale within 1 hour prior to third dose and at 2 hours post third dose (participants with baseline in-clinic Numeric Rating Scale ≥3)
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Measured: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale within 1 hour prior to third dose and at 2 hours post third dose (participants with baseline clinic Numeric Rating Scale ≥4)
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Measured: Within 1 hour prior to third dose to 2 hours post third dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous Urticaria (CSU)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT07665996
- Sponsor's protocol ID
- TLL-018-206
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Clinical Trial Assessing the Rapid Onset Characteristics of TLL-018 in Subjects With Moderate-to-Severe Chronic Spontaneous Urticaria Who Fail to Achieve Adequate Control With Second-Generation H1 Antihistamines
- ClinicalTrials.gov ID
- NCT07665996
- Acronym / sponsor ID
- TLL-018-206
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jun 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.
The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.
The main objectives are:
To evaluate the rapid onset characteristics of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.
To evaluate the safety profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.
To evaluate the pharmacokinetic (PK) profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.
Participants will be randomly allocated at a 1:1:1 ratio to receive TLL-018 10 mg, TLL-018 20 mg, or placebo orally after meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: TLL-018, Drug: PlaceboTLL-018 10 mg |
| Arm 2 | Experimental | Drug: TLL-018TLL-018 20 mg |
| Arm 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged between 18 and 75.
- Diagnosis of CSU refractory to second-generation H1-AH.
- CSU diagnosis for ≥ 6 months.
- The presence of itch and hives despite current use of an approved dose of H1-AH for ≥ 6 weeks prior to screening visit.
- UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (ISS range 0-21) ≥ 8 during 7 days prior to randomization (Day 1), and ISS ≥2 on the day of randomization.
Key exclusion criteria (38 listed)
- Participants who meet the diagnostic criteria for chronic spontaneous urticaria (CSU) shall be excluded if they present with any of the following conditions:
- Participants with any of the following prior therapies or concomitant medications cannot be enrolled:
- History of allergy to any component of the investigational medicinal product or H1-antihistamines, or history of anaphylactic shock.
- Abnormal findings at screening that meet any of the following criteria:
- Any other condition or circumstance that, in the investigator's judgment, renders the participant unsuitable for participation in this study.
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-018Participants will receive TLL-018 10 mg (1 tablet) and placebo (1 tablet) orally after meals, with a dosing interval of 12 hours (±15 minutes) | Drug | Arm 1 |
| TLL-018Participants will receive TLL-018 20 mg (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes) | Drug | Arm 2 |
| PlaceboParticipants will receive placebo (2 tablets) orally after meals, with a dosing interval of 12 hours (±15 minutes) | Drug | Arm 1, Arm 3 |
Primary outcome
Time to first achievement of ≥1-point reduction from baseline in in-clinic Itch Severity Scale after first dose
Time frame: First dose up to day 2
Time from first dose until the first clinic assessment where a ≥1-point reduction from baseline in Itch Severity Scale (ISS, range 0-3; higher = worse itch) at in-clinic evaluation.
Time to first ≥1-point reduction from baseline in in-clinic Hive Severity Scale after first dose
Time frame: First dose up to day 2
Time from first dose to the first in-clinic assessment with ≥1-point reduction from baseline on Hive Severity Scale (HSS, 0-3).
Change from baseline in in-clinic Itch Severity Scale post first dose
Time frame: First dose up to 8 hours post first dose
Mean change from baseline of in-clinic ISS (0-3) at scheduled timepoints after first dose.
Change from baseline in in-clinic Hive Severity Scale post first dose
Time frame: First dose up to 8 hours post first dose
Mean change from baseline of in-clinic Hive Severity Scale (0-3) at scheduled timepoints after first dosing.
Change from baseline in in-clinic Numeric Rating Scale post first dose
Time frame: First dose up to 8 hours post first dose
Mean change from baseline of in-clinic Numeric Rating Scale (clinic NRS, 0-10) at scheduled timepoints after first dosing.
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale post first dose
Time frame: First dose up to 8 hours post first dose
Percentage of participants achieving ≥1-point reduction from baseline on in-clinic Itch Severity Scale (0-3) at each in-clinic timepoint post first dose.
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale post first dose
Time frame: First dose up to 8 hours post first dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale post first dose (baseline clinic Numeric Rating Scale ≥3)
Time frame: First dose up to 8 hours post first dose
Percentage of participants with baseline NRS score ≥3 who attain ≥3-point reduction from baseline on NRS (0-10) at each in-clinic assessment after first dose.
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale post first dose (baseline clinic Numeric Rating Scale ≥4)
Time frame: First dose up to 8 hours post first dose
Percentage of participants with baseline Numeric Rating Scale score ≥4 who attain ≥4-point reduction from baseline on NRS (0-10) at each in-clinic assessment after first dose.
Change from baseline in Itch Severity Scale at Day 0.5, Day 1, Day 1.5 post first dose
Time frame: First dose up to 1.5 days post first dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Change from baseline in Hive Severity Scale at Day 0.5, Day 1, Day 1.5 post first dose
Time frame: First dose up to 1.5 days post first dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Change from baseline in Worst Itch Numeric Rating Scale at Day 0.5, Day 1, Day 1.5 post first dose
Time frame: First dose up to 1.5 days post first dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Change from baseline in in-clinic Itch Severity Scale at 2 hours post second dose
Time frame: 2 hours post second dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Change from baseline in in-clinic Hive Severity Scale at 2 hours post second dose
Time frame: 2 hours post second dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Change from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose
Time frame: 2 hours post second dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale at 2 hours post second dose
Time frame: 2 hours post second dose
Itch Severity Scale (ISS, range 0-3; higher = worse itch)
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale at 2 hours post second dose
Time frame: 2 hours post second dose
Hive Severity Scale (HSS, range 0-3; higher = worse hive)
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose (baseline clinic Numeric Rating Scale ≥3)
Time frame: 2 hours post second dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale at 2 hours post second dose (baseline clinic Numeric Rating Scale ≥4)
Time frame: 2 hours post second dose
Itch Numeric Rating Scale (NRS): from 0 (no itch) to 10 (worst imaginable itch)
7 secondary outcomes
Change from baseline in in-clinic Itch Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Time frame: Within 1 hour prior to third dose to 2 hours post third dose
Change from baseline in in-clinic Hive Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Time frame: Within 1 hour prior to third dose to 2 hours post third dose
Change from baseline in in-clinic Numeric Rating Scale within 1 hour prior to third dose and at 2 hours post third dose
Time frame: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Itch Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Time frame: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥1-point reduction from baseline in in-clinic Hive Severity Scale within 1 hour prior to third dose and at 2 hours post third dose
Time frame: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥3-point reduction from baseline in in-clinic Numeric Rating Scale within 1 hour prior to third dose and at 2 hours post third dose (participants with baseline in-clinic Numeric Rating Scale ≥3)
Time frame: Within 1 hour prior to third dose to 2 hours post third dose
Proportion of participants with ≥4-point reduction from baseline in in-clinic Numeric Rating Scale within 1 hour prior to third dose and at 2 hours post third dose (participants with baseline clinic Numeric Rating Scale ≥4)
Time frame: Within 1 hour prior to third dose to 2 hours post third dose
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Spontaneous Urticaria (CSU)
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
Chronic Spontaneous Urticaria (CSU)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TLL-018 in people with Chronic Spontaneous Urticaria (CSU), 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 9 inclusion and 38 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 24 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first achievement of ≥1-point reduction from baseline in in-clinic Itch Severity Scale after first dose (time frame: First dose up to day 2). The study lists 19 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 24 Aug 2026.