Actively Recruiting
A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of TLL-018 Tablets in Adults With Moderate-to-Severe Chronic Spontaneous Urticaria Uncontrolled by Second-Generation H1-antihistamines
Led by Hangzhou Highlightll Pharmaceutical Co., Ltd · Updated on 2024-12-27
436
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TLL-018 in adults with moderate-to-severe chronic spontaneous urticaria (CSU) who have not responded well to second-generation H1-antihistamines. This phase 3, randomized, double-blind, placebo-controlled study involves participants aged 18 to 75 with CSU symptoms lasting at least 6 months and active itching and hives despite treatment. The trial aims to improve symptoms measured by standardized scores such as UAS7 and ISS7 over 12 weeks. Participants are assigned to receive either TLL-018 tablets or placebo tablets initially. Those taking TLL-018 will take one tablet twice daily for 52 weeks. Participants on placebo will take placebo tablets twice daily for 12 weeks, then switch to TLL-018 tablets twice daily for the following 40 weeks. This design allows comparison of TLL-018 against placebo and then extended treatment. During the study, participants will regularly report symptom scores and complete daily diaries to track urticaria activity. Researchers will perform safety monitoring, clinical evaluations, and laboratory tests to assess treatment effects and side effects. The main outcomes focus on changes in urticaria activity scores at 12 weeks, with ongoing assessments throughout the full 52-week treatment period.
CONDITIONS
Official Title
A Study of Efficacy and Safety of TLL-018 in CSU Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75.
- Diagnosed with chronic spontaneous urticaria refractory to second-generation H1-antihistamines.
- CSU diagnosis for at least 6 months.
- Presence of itching and hives despite current approved dose of second-generation H1-antihistamines prior to screening.
- UAS7 score of 16 or higher and itch component of UAS7 score of 8 or higher during 7 days prior to randomization.
- Taking a stable standard dose of second-generation H1-antihistamines according to local guidelines.
- Willing and able to complete the urticaria patient daily diary (UPDD) for the duration of the study.
- Evidence of urticaria confirmed by the investigator prior to randomization.
- Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test before randomization.
- Participants must use adequate barrier contraception during treatment and for at least 90 days after treatment; must avoid sperm or ovum donation for at least six months after treatment.
You will not qualify if you...
- Presence of other chronic urticarias or induced urticaria with a clearly defined underlying cause.
- Any disease causing urticaria or angioedema symptoms other than CSU.
- Chronic pruritic diseases affecting efficacy judgment, such as psoriasis or atopic dermatitis.
- History of malignancy, herpes zoster, or active tuberculosis.
- Progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, or cerebral disease.
- Investigator judges participation poses unacceptable risk.
- Use of any study drug within 4 weeks or less than 5 half-lives before randomization.
- Use of biological agents within 3 months or 5 half-lives before randomization.
- Use of immunosuppressive or modulatory drugs within 4 weeks before randomization.
- Receipt of any live vaccine within 2 months before randomization or planned during the study.
- Major surgery within 4 weeks before randomization or planned after enrollment.
- Blood donation over 400 ml or blood transfusion within 3 months prior to the study.
- History of drug or alcohol abuse within 6 months prior to screening.
- Allergy to ingredients of H1-antihistamines or TLL-018.
- Abnormal laboratory test results interfering with the study.
- Other conditions deemed inappropriate for participation by investigators.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
Q
Qianjin Lu, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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