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A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE-RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF EVO756 IN ADULTS WITH MODERATE TO SEVERE CHRONIC SPONTANEOUS URTICARIA

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic Spontaneous Urticaria
Date of first enrollment	27/05/2025
Target sample size	16
Countries of recruitment	US,Japan,Canada,Japan,Bulgaria,Japan,Germany,Japan,Poland,Japan,Hungary,Japan,Spain,Japan,Italy,Japan
Study type	Interventional
Intervention(s)	Subjects will be treated with EVO756 or placebo for 12 weeks.

Outcome(s)

Primary Outcome	Mean change from baseline in UAS7 at Week 12
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Male or female aged >-18 years at Screening. 2. Capable of providing written informed consent and willing and able to comply with study requirements. 3. Confirmed CSU diagnosis for >- 3 months with an inadequate response to H1 antihistamines. 4. Subjects who are taking H1-antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study. 5. WOCBP who are sexually active with a non-sterile male partner must be willing to use highly effective contraceptive methods at least 28 days prior to Day 1 and throughout the study and for 90 days after the last study drug administration 6. Male subjects who are not vasectomized for at least 6 months prior to screening, and who are sexually active with a WOCBP must be willing to use an effective barrier method of contraception from the first study drug administration until at least 90 days after the last study drug administration. Female partners of male subjects who are WOCBP should use acceptable contraceptive methods at least 28 days prior to Day 1, throughout the study, and for 90 days after the last study drug administration. 7. Male subjects must agree to not donate sperm from the first study drug administration until 90 days following the last study drug administration. 8. Female subjects must agree to not donate oocytes or undergo in vitro fertilization from the first study drug administration until 90 days following the last study drug administration.
Exclude criteria	1.Patients with serious illnesses such as heart, liver, kidney, lung, or blood diseases that make it difficult for them to participate in the clinical trial, as determined by the physician in charge. 2.Positive test for HIV, hepatitis B, or hepatitis C. 3.Liver and kidney function values that exceed the prescribed figures 4.History of hypersensitivity to EVO756, its components, or drugs of similar classes. 5.History of clinically significant drug or alcohol abuse in the last year prior to Day 1. 6.Pregnant, lactating, and possibly pregnant women or women planning a pregnancy within the study period and up to 3 months post treatment completion. 7.History of a major surgery within 8 weeks prior to Day 1, or major surgery planned during the study. 8.History of malignancy of any organ system treated or untreated, within the past 5 years.