A Phase 2 interventional study of TLL-018 tablets and TLL-018 tablets in Chronic Spontaneous Urticaria (CSU), sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment
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
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's planned enrollment of 140 is above the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Hangzhou Highlightll Pharmaceutical Co., Ltd is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TLL-018 tablets taken orally 10 mg (1 tablet) twice daily for 12 weeks
Drug: TLL-018 tablets
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
Drug: TLL-018 tablets
TLL-018 tablets taken orally 20 mg (2 tablets) twice daily for 12 weeks
Drug: TLL-018 tablets
Placebo taken orally (2 tablets) twice daily for 12 weeks
Drug: Placebo
TLL-018 tablets taken orally 10 mg (1 tablet) twice daily
TLL-018 tablets taken orally 20 mg (2 tablets) twice daily
Placebo taken orally (2 tablets) twice daily for 12 weeks
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).
Time frame: 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.
Time frame: 12 weeks
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: TLL-018
Hangzhou Highlightll Pharmaceutical Co., Ltd →