A Study of Efficacy and Safety of TLL-018 in CSU Participants
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
Hangzhou Highlightll Pharmaceutical Co., Ltd
436 participants
Dec 24, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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.
- 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.
Exclusion Criteria18
- 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.
- 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.
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Interventions
Oral TLL-018 tablets taken orally 1 pieces BlD for 52 weeks
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06396026