A Study of Efficacy and Safety of TLL-018 in CSU Participants

NCT06396026 | Recruiting Phase 3

• 1 other identifier: TLL-018-303
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (6)

• Change from baseline in HSS7 at Week 12

  12 weeks

• Proportion of Participants With UAS7≤6 Response at Week 12

  12 weeks

• Proportion of Participants With UAS7=0 Response at Week 12

  12 weeks

• Proportion of Participants With DLQI=0/1 Response at Week 12

  12 weeks

• Change from baseline in DLQI at Week 12

  12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

TLL018 tablets,1piece,BID

Drug: TLL-018 tablets

Arm 2

PLACEBO COMPARATOR

Placebo tablets,1piece,BID

Drug: Placebo tablets

Interventions

TLL-018 tablets DRUG

Oral TLL-018 tablets taken orally 1 pieces BlD for 52 weeks

Arm 1

Placebo tablets DRUG

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.

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (1)

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qianjin Lu, Ph.D

CONTACT

+86-025-85478030; qianlu5860@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug: TLL-018 Drug: Placebo

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: December 24, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)