Actively Recruiting
A Study of Efficacy and Safety of TLL-018 in CSU Participants
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
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.
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
AI-Powered 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
CONTACT
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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