AzTrials
AzTrials

Chronic Spontaneous UrticariaPhase 1NCT05373355

Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.

A Phase 1 study testing TLL018 tablets in people with Chronic Spontaneous Urticaria, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
TLL018 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteChina
Study dates
10 May 2022to 7 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have had a diagnosis of moderate to severe Chronic Spontaneous Urticaria for at least 6 months prior to Baseline;
  • Subjects with moderate to severe Chronic Spontaneous Urticaria UAS7 score ≥16 at Baseline;
  • Able and willing to give written informed consent.

Who cannot join

  • Other types of Chronic Urticaria (such as Artificial urticaria, cold-contact urticaria, heat-contact urticaria etc);
  • Other disease with symptoms of urticaria or angioedema, e.g., Urticaria vasculitis, color Vegetarian urticaria, erythema multiforme;
  • History or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis;
  • Any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College

    Nanjing, Jiangsu, 210042

Other trials in China

About this study

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria.

Read the detailed description

Successfully screened subjects will be randomized in a ratio of 1：1：1. After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.

Clinical Urticaria Activity Score (UAS), dermatological Quality of Life Index (DLQI), physical exams and Laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.

Being tested
TLL018 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.

  • TLL018 tabletsDrug

    Also called TLL018 Placeboes

    Oral tablets administered at different doses BID daily for 12 weeks.

Study groups in NCT05373355
Study groupRoleWhat they receive
Cohort 1ExperimentalTLL018 tablets 1piece,BID
Receives: Drug: TLL018 tablets
Cohort 2ExperimentalTLL018 tablets 3pieces, BID
Receives: Drug: TLL018 tablets
Cohort 3Placebo comparatorTLL018 placeboes 3pieces, BID
Receives: Drug: TLL018 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

    Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

    Measured: From day 1 to Weeks 4

  2. adverse events (AEs) according to severity

    Number of adverse events (AEs) according to severity

    Measured: From day 1 to Weeks 4

  3. blood pressure from baseline

    Change of blood pressure from baseline

    Measured: From day 1 to Weeks 4

  4. pulse rate from baseline

    Change of pulse rate from baseline

    Measured: From day 1 to Weeks 4

  5. respiratory rate from baseline

    Change of respiratory rate from baseline

    Measured: From day 1 to Weeks 4

  6. temperature from baseline

    Change of oral temperature from baseline

    Measured: From day 1 to Weeks 4

  7. clinical laboratory abnormalities compared to baseline

    Number of participants with clinical laboratory abnormalities compared to baseline

    Measured: From day 1 to Weeks 4

  8. ECG parameters from baseline

    Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline

    Measured: From day 1 to Weeks 4

  9. physical examination findings from baseline

    Number of participants with changes in physical examination findings from baseline

    Measured: From day 1 to Weeks 4

  10. Cmax of TLL018

    Maximum observed plasma concentration (Cmax) of TLL018

    Measured: 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 8 hours post-dose

Secondary outcomes (15)

  1. treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

    Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

    Measured: From week 4 to Weeks 12

  2. adverse events (AEs) according to severity

    Number of adverse events (AEs) according to severity

    Measured: From week 4 to Weeks 12

  3. blood pressure from baseline

    Change of blood pressure from baseline

    Measured: From week 4 to Weeks 12

  4. pulse rate from baseline

    Change of pulse rate from baseline

    Measured: From week 4 to Weeks 12

  5. respiratory rate from baseline

    Change of respiratory rate from baseline

    Measured: From week 4 to Weeks 12

  6. temperature from baseline

    Change of oral temperature from baseline

    Measured: From week 4 to Weeks 12

  7. clinical laboratory abnormalities compared to baseline

    Number of participants with clinical laboratory abnormalities compared to baseline

    Measured: From week 4 to Weeks 12

  8. ECG parameters from baseline

    Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline

    Measured: From week 4 to Weeks 12

  9. physical examination findings from baseline

    Number of participants with changes in physical examination findings from baseline

    Measured: From week 4 to Weeks 12

  10. UAS7 score decreased from baseline at week 4

    Change in mean value of UAS7 score from baseline at week 4 when comparing TLL-018 with placebo

    Measured: Baseline to Week 4

  11. UAS7 score decreased from baseline at week 8

    Change in mean value of UAS7 score from baseline at week 8 when comparing TLL-018 with placebo

    Measured: Time Frame: Baseline to Week 8

  12. UAS7 score decreased from baseline at week 12

    Change in mean value of UAS7 score from baseline at week 12 when comparing TLL-018 with placebo

    Measured: Baseline to Week 12

  13. DLQI score decreased from baseline at week 4

    Change in mean value of DLQI score from baseline at week 4 when comparing TLL-018 with placebo

    Measured: Baseline to Weeks 4

  14. DLQI score decreased from baseline at week 8

    Change in mean value of DLQI score from baseline at week 8 when comparing TLL-018 with placebo

    Measured: Baseline to Weeks 8

  15. DLQI score decreased from baseline at week 12

    Change in mean value of DLQI score from baseline at week 12 when comparing TLL-018 with placebo

    Measured: Baseline to Weeks 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2022
  2. Study start10 May 2022
  3. Primary completion7 Sep 2023
  4. Study completion7 Sep 2023

Resources

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05373355
Sponsor's protocol ID
TLL018-204
Status last verified
Oct 2023
First submitted
10 May 2022
Last updated
1 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yao X, Liu Y, Luo Y, Liu X, Zhou M, Yang B, Liu L, Li L, Liu W, Man X, Chen A, Shi Y, Ding Y, Sun Q, Tao J, Chen J, Liang C, Lu Q. Safety and efficacy of the selective tyrosine kinase 2/Janus kinase 1 inhibitor TLL-018 in patients with moderate-to-severe chronic spontaneous urticaria with inadequate response to H1 antihistamines: a phase Ib, randomized, double-blind, placebo-controlled pilot study. Br J Dermatol. 2026 Jul 17;195(2):222-231. doi: 10.1093/bjd/ljag092.

    PubMed 41834239

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TLL018 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Mar 2024. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs (time frame: From day 1 to Weeks 4). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05373355, which also lists 1 linked publication.

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 1 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in