Chronic Spontaneous Urticaria (CSU)Phase 2NCT07764003
A Study of Efficacy and Safety of TLL-018 in CSU Participants With Inadequate Response to 2nd-generation H1-AHs
A Phase 2 study testing TLL-018 tablets in people with Chronic Spontaneous Urticaria (CSU), run by Hangzhou Highlightll Pharmaceutical Co., Ltd.
Trial summary
The goal of this clinical trial is to learn if different doses of TLL-018 works to treat in moderate-to-severe chronic spontaneous urticaria (CSU) participants . It will also learn about the safety of TLL-018. 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 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 31 Dec 2027
- Phase
- Phase 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 prior to randomization.
- UAS7 score (range 0-42) ≥ 16 and ISS7 (range 0-21) ≥ 8 during 7 days prior to randomization.
- Participants were required to take a stable standard dose of a second generation H1-AH concomitantly according to local guidelines.
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- Willing and able to complete UPDD during the study; participants must not have more than one missing UPDD symptom score (either morning or evening) within the 7-day period prior to randomization.
- Evidence of urticaria confirmed by the investigator prior to randomization.
- Women of Child Bearing Potential (WOCBP) should not be pregnant or breastfeeding and the pregnancy test should be negative before randomization.
- Participants and their partners must agree to 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.
- The trial participant understands the informed consent form and voluntarily agrees to participate in the study.
Who cannot join
- Participants meeting diagnosis criteria of chronic spontaneous urticaria with the following concomitant diseases cannot be enrolled:
- Progressive or uncontrolled signs or symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurologic, psychiatric, or cerebral disease, as judged by the investigator to place the subject at unacceptable risk by study participation.
- Clearly defined underlying etiology for chronic urticarias other than CSU. E.g. induced urticaria, including but not limited to artificial urticaria.
- Any disease, which may have symptoms of urticaria and/or angioedema, including but not limited to urticaria and vasculitis.
- Suffering from other chronic pruritic diseases that may affect the assessment of efficacy, such as psoriasis, atopic dermatitis, etc.
- Previous malignancy, herpes zoster, active tuberculosis.
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- Participants with any of the following prior therapies or medications cannot be enrolled:
- Have received treatment with JAK inhibitors (e.g., tofacitinib, baricitinib, ruxolitinib, etc.) or BTK inhibitors (e.g., remibrutinib) within 4 weeks prior to randomization;
- Have received any investigational product within 4 weeks prior to randomization or within 5 elimination half-lives, whichever is longer;
- Have received omalizumab/omalizumab biosimilar treatment within 4 months prior to randomization;
- Have received biologics with potential therapeutic effects for chronic spontaneous urticaria (e.g., dupilumab, etc.) within 3 months prior to randomization or within 5 elimination half-lives, whichever is longer;
- Have received immunosuppressive or immunomodulatory drug therapy within 4 weeks prior to randomization, e.g., systemic corticosteroids, etc.
- Known allergy to any active ingredients or excipients of H1-AH or TLL-018.
- Abnormal laboratory test results that may interfere with the conduct of the study by the assessment from the investigator.
- Any other situation or condition that, in the investigator's judgment, would render the participant unsuitable for study participation.
About this study
Official title: A Randomized, Double-blind, Phase II Study of Efficacy and Safety of TLL-018 in Moderate-to-Severe CSU Participants With Inadequate Response to Second-Generation H1 Antihistamines
The goal of this clinical trial is to learn if different doses of TLL-018 works to treat in moderate-to-severe chronic spontaneous urticaria (CSU) participants . It will also learn about the safety of TLL-018. The main questions it aims to answer are:
Which is the best regimen of TLL-018 administration in reducing or eliminating symptoms (hives, itch, and/or angioedema) ? What medical problems do participants have when taking TLL-018? Researchers will compare different doses of TLL-018, and placebo (a look-alike substance that contains no drug).
Read more
Participants will:
Take TLL-018 or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Being tested
- TLL-018 tablets, 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-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
PlaceboDrug
Placebo taken orally (2 tablets) twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | TLL-018 tablets taken orally 10 mg (1 tablet) twice daily for 12 weeks Receives: Drug: TLL-018 tablets |
| Arm B | Experimental | TLL-018 tablets taken orally 20 mg (2 tablets) twice daily for 4 weeks, followed by TLL-018 tablets taken orally 10 mg (1 tablet) twice daily for 8 weeks Receives: Drug: TLL-018 tablets |
| Arm C | Experimental | TLL-018 tablets taken orally 20 mg (2 tablets) twice daily for 12 weeks Receives: Drug: TLL-018 tablets |
| Arm D | Placebo comparator | Placebo taken orally (2 tablets) twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weekly Itch Severity Score at Week 12
The weekly Itch Severity Score (ISS7) is the itch severity score for 7 days, and it ranges from 0 to 21 (higher = worse itch).
Measured: 12 weeks
Change from baseline in weekly Urticaria Activity Score at Week 12
The weekly Urticaria Activity Score (UAS7) is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Measured: 12 weeks
Secondary outcomes (5)
Change from baseline in weekly Hive Severity Score
Change from baseline in weekly hive severity score (HSS7) at week 1, 2, 4, 8, and 12.
The weekly hive severity score (HSS7) ranges from 0 to 21 (higher = worse).
Measured: 12 weeks
Proportion of Participants With weekly Urticaria Activity Score ≤ 6
Proportion of participants achieve disease activity control (weekly Urticaria Activity Score≤6) at Week 1, 2, 4, 8, and 12.
The weekly Urticaria Activity Score is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Measured: 12 weeks
Proportion of Participants With weekly Urticaria Activity Score = 0
Proportion of participants achieve achieve complete absence of hives and itch (weekly Urticaria Activity Score=0) at Week 1, 2, 4, 8, and 12.
The weekly Urticaria Activity Score is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Measured: 12 weeks
Change from baseline in Dermatology Life Quality Index score
Change from baseline in Dermatology Life Quality Index score at week 4, 8,and 12.
The Dermatology Life Quality Index (DLQI) is a widely used patient-reported outcome (PRO) instrument with a range of 0-30, higher scores indicate greater impairment of quality of life.
Measured: 12 weeks
Proportion of Participants With Dermatology Life Quality Index score=0/1
Proportion of Participants With Dermatology Life Quality Index score=0/1 at week 4, 8, and 12.
The Dermatology Life Quality Index (DLQI) is a widely used patient-reported outcome (PRO) instrument with a range of 0-30, higher scores indicate greater impairment of quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start10 Sep 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 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
- NCT07764003
- Sponsor's protocol ID
- TLL-018-209
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 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 Randomized, Double-blind, Phase II Study of Efficacy and Safety of TLL-018 in Moderate-to-Severe CSU Participants With Inadequate Response to Second-Generation H1 Antihistamines
- ClinicalTrials.gov ID
- NCT07764003
- Acronym / sponsor ID
- TLL-018-209
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 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.
The goal of this clinical trial is to learn if different doses of TLL-018 works to treat in moderate-to-severe chronic spontaneous urticaria (CSU) participants . It will also learn about the safety of TLL-018. The main questions it aims to answer are:
Which is the best regimen of TLL-018 administration in reducing or eliminating symptoms (hives, itch, and/or angioedema) ? What medical problems do participants have when taking TLL-018? Researchers will compare different doses of TLL-018, and placebo (a look-alike substance that contains no drug).
Participants will:
Take TLL-018 or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms
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 tablets taken orally 10 mg (1 tablet) twice daily for 12 weeks |
| Arm B | Experimental | Drug: TLL-018 tabletsTLL-018 tablets taken orally 20 mg (2 tablets) twice daily for 4 weeks, followed by TLL-018 tablets taken orally 10 mg (1 tablet) twice daily for 8 weeks |
| Arm C | Experimental | Drug: TLL-018 tabletsTLL-018 tablets taken orally 20 mg (2 tablets) twice daily for 12 weeks |
| Arm D | Placebo comparator | Drug: PlaceboPlacebo taken orally (2 tablets) twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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 prior to randomization.
- UAS7 score (range 0-42) ≥ 16 and ISS7 (range 0-21) ≥ 8 during 7 days prior to randomization.
Key exclusion criteria (15 listed)
- Participants meeting diagnosis criteria of chronic spontaneous urticaria with the following concomitant diseases cannot be enrolled:
- Participants with any of the following prior therapies or medications cannot be enrolled:
- Known allergy to any active ingredients or excipients of H1-AH or TLL-018.
- Abnormal laboratory test results that may interfere with the conduct of the study by the assessment from the investigator.
- Any other situation or condition that, in the investigator's judgment, would render the participant unsuitable for study participation.
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, Arm B |
| TLL-018 tabletsTLL-018 tablets taken orally 20 mg (2 tablets) twice daily | Drug | Arm B, Arm C |
| PlaceboPlacebo taken orally (2 tablets) twice daily for 12 weeks | Drug | Arm D |
Primary outcome
Change from baseline in weekly Itch Severity Score at Week 12
Time frame: 12 weeks
The weekly Itch Severity Score (ISS7) is the itch severity score for 7 days, and it ranges from 0 to 21 (higher = worse itch).
Change from baseline in weekly Urticaria Activity Score at Week 12
Time frame: 12 weeks
The weekly Urticaria Activity Score (UAS7) is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
5 secondary outcomes
Change from baseline in weekly Hive Severity Score
Time frame: 12 weeks
Proportion of Participants With weekly Urticaria Activity Score ≤ 6
Time frame: 12 weeks
Proportion of Participants With weekly Urticaria Activity Score = 0
Time frame: 12 weeks
Change from baseline in Dermatology Life Quality Index score
Time frame: 12 weeks
Proportion of Participants With Dermatology Life Quality Index score=0/1
Time frame: 12 weeks
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
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLL-018 tablets in people with Chronic Spontaneous Urticaria (CSU), run by Hangzhou Highlightll Pharmaceutical Co., Ltd.
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 11 inclusion and 15 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.
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 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.
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?
Change from baseline in weekly Itch Severity Score at Week 12 (time frame: 12 weeks). 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 24 Aug 2026.