Chronic Spontaneous UrticariaPhase 3NCT06396026
A Study of Efficacy and Safety of TLL-018 in CSU Participants
A Phase 3 study testing TLL-018 tablets in people with Chronic Spontaneous Urticaria, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) With Inadequate Controll 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
- 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
- 440 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to 30 Dec 2026
- Phase
- Phase 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
- Aged between 18 and 75.
- Diagnosis of CSU refractory to secomd-generation H1-AH.
- CSU diagnosis for ≥ 6 months.
- The presence of itch and hivese despite current use of an approved dose of H1-AH prior to screening visit.
- UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1).
- 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 for the duration of the study.
- 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 (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 meeting Chinese Guidelines for Urticaria Diagnosis and Treatment with the following concomitant diseases cannot be enrolled:
- 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 judgment of efficacy results, such as psoriasis, atopic dermatitis, etc.
- Previous malignancy, herpes zoster, active tuberculosis.
- Other symptoms of progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, or cerebral disease.
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- Taking part in this study, in the opinion of the investigator, places the patient at unacceptable risk.
- Participants with any of the following prior therapies or concomitant medications cannot be enrolled:
- Have received any study drug within 4 weeks or less than 5 elimination of half-life period before randomization (whichever is longer).
- Have received biological agent within 3 months or 5 elimination of half-life period prior to randomization (whichever is longer).
- Have received immunosuppressive/modulatory drug within 4 weeks before randomization.
- Have received any live vaccine within 2 months before randomization or plan to receive a live vaccine during the study.
- Have experienced major surgery within 4 weeks before randomization, or expected to receive major surgical treatment after enrollment;
- Have donated blood more than 400 ml or received blood transfusion within 3 months prior to the study.
- History of drug or alcohol abuse within 6 months prior to screening.
- Allergy to ingredients or excipients of H1-AH or TLL-018.
- Laboratory test results are abnormal and may interfere the study judged by investigators.
- Participants are not appropriate for participation in any other situation or condition in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences
Nanjing, Jiangsu
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria With Inadequate Controll to Second Generation H1-antihistamines
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) With Inadequate Controll to Second Generation H1-antihistamines.
Read the detailed description
This is a randomized, double-blind, single-dummy, placebo-parallel-group, phase 3 study to assess the safety and efficacy of TLL-018 in Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) participants who had an Inadequate Controll to Second Generation H1-antihistamines.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- TLL-018 tablets, Placebo tablets
- 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
Oral TLL-018 tablets taken orally 1 pieces BlD for 52 weeks
Placebo tabletsDrug
Oral Placebo tablets taken orally 1 pieces BlD for 12 weeks and then Oral TLL-018 tablets taken orally 1 pieces BlD for 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | TLL018 tablets,1 tablet ,BID Receives: Drug: TLL-018 tablets |
| Arm 2 | Placebo comparator | Placebo tablets, 1 tablet ,BID Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in UAS7 at Week 12
To demonstrate that TLL-018 is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in weekly Urticaria Activity Score (UAS7) at week 12.
The 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
Change from baseline in ISS7 at Week 12
To demonstrate that TLL-018 is superior to placebo in CSU with respect to change from baseline in ISS7 at Week 12 by assessing absolute change from baseline in weekly Itch Severity Score (ISS7) at week 12.
The ISS7 is the itch severity score for 7 days, and it ranges from 0 to 21.
Measured: 12 weeks
Secondary outcomes (6)
Change from baseline in HSS7 at Week 12
To demonstrate that TLL-018 is superior to placebo in CSU with respect to change from baseline in HSS7 at Week 12 by assessing absolute change from baseline in hive severity score (HSS7) at week 12.
The HSS7 is the hive severity score for 7 days, and it ranges from 0 to 21.
Measured: 12 weeks
Proportion of Participants With UAS7≤6 Response at Week 12
To demonstrate that a greater proportion of participants achieve disease activity control UAS7≤6 at Week 12 who are treated with TLL-018 compared to placebo-treated participants by assessing achievement of UAS7≤6 at week 12.
Measured: 12 weeks
Proportion of Participants With UAS7=0 Response at Week 12
To demonstrate that a greater proportion of participants achieve complete absence of hives and itch (UAS7 = 0) at Week 12 who are treated with TLL-018 compared to placebo-treated participants by achievement of UAS7 = 0 at week 12.
Measured: 12 weeks
Proportion of Participants With DLQI=0/1 Response at Week 12
To demonstrate that a greater proportion of participants who are treated with TLL-018 achieve DLQI = 0/1 at Week 12 compared to placebo-treated participants by assessing achievement of DLQI = 0/1 at week 12.
Measured: 12 weeks
Change from baseline in DLQI at Week 12
To demonstrate that TLL-018 is superior to placebo in CSU with respect to change from baseline in DLQI at Week 12 by assessing absolute change from baseline in DLQI at week 12.
Measured: 12 weeks
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
To demonstrate the safety and tolerability of TLL-018 by assessing occurrence of treatment emergent adverse events and serious adverse events during the study.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start27 Mar 2024
- Primary completion23 Oct 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: TLL-018 Drug: Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 440 participants (actual)
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
- NCT06396026
- Sponsor's protocol ID
- TLL-018-303
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria With Inadequate Controll to Second Generation H1-antihistamines
- ClinicalTrials.gov ID
- NCT06396026
- Acronym / sponsor ID
- TLL-018-303
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 May 2024 (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.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) With Inadequate Controll to Second Generation H1-antihistamines.
Detailed description
This is a randomized, double-blind, single-dummy, placebo-parallel-group, phase 3 study to assess the safety and efficacy of TLL-018 in Moderate-to-Severe Chronic Spontaneous Urticaria (CSU) participants who had an Inadequate Controll to Second Generation H1-antihistamines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Drug: TLL-018 Drug: Placebo
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: TLL-018 tabletsTLL018 tablets,1 tablet ,BID |
| Arm 2 | Placebo comparator | Drug: Placebo tabletsPlacebo tablets, 1 tablet ,BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged between 18 and 75.
- Diagnosis of CSU refractory to secomd-generation H1-AH.
- CSU diagnosis for ≥ 6 months.
- The presence of itch and hivese despite current use of an approved dose of H1-AH prior to screening visit.
- UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1).
Key exclusion criteria (18 listed)
- Participants meeting Chinese Guidelines for Urticaria Diagnosis and Treatment with the following concomitant diseases cannot be enrolled:
- Participants with any of the following prior therapies or concomitant medications cannot be enrolled:
- Have experienced major surgery within 4 weeks before randomization, or expected to receive major surgical treatment after enrollment;
- Have donated blood more than 400 ml or received blood transfusion within 3 months prior to the study.
- History of drug or alcohol abuse within 6 months prior to screening.
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 tabletsOral TLL-018 tablets taken orally 1 pieces BlD for 52 weeks | Drug | Arm 1 |
| Placebo tabletsOral Placebo tablets taken orally 1 pieces BlD for 12 weeks and then Oral TLL-018 tablets taken orally 1 pieces BlD for 40 weeks. | Drug | Arm 2 |
Primary outcome
Change from baseline in UAS7 at Week 12
Time frame: 12 weeks
To demonstrate that TLL-018 is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in weekly Urticaria Activity Score (UAS7) at week 12. The 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.
Change from baseline in ISS7 at Week 12
Time frame: 12 weeks
To demonstrate that TLL-018 is superior to placebo in CSU with respect to change from baseline in ISS7 at Week 12 by assessing absolute change from baseline in weekly Itch Severity Score (ISS7) at week 12. The ISS7 is the itch severity score for 7 days, and it ranges from 0 to 21.
6 secondary outcomes
Change from baseline in HSS7 at Week 12
Time frame: 12 weeks
Proportion of Participants With UAS7≤6 Response at Week 12
Time frame: 12 weeks
Proportion of Participants With UAS7=0 Response at Week 12
Time frame: 12 weeks
Proportion of Participants With DLQI=0/1 Response at Week 12
Time frame: 12 weeks
Change from baseline in DLQI at Week 12
Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: 52 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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 3 study testing TLL-018 tablets in people with Chronic Spontaneous Urticaria, 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 10 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 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 phase mean?
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?
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 UAS7 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 3 Jun 2026.