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New treatment option for Allergic Diseases
Official title Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
ClinicalTrials.gov ID: NCT07415551
What this study is testing
What is Lesigercept?
Lesigercept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for allergic diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).
- Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.
- Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.
- ≥80% adherence to antihistamines during screening.
You likely can't join if
- Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.
- Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or...
- History of malignancy within 5 years (except certain cured skin/cervical cancers) or chronic urticaria with known etiology other than CSU (e.g...
- Active or high-risk parasitic infections, chronic/recurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity/anaphylaxis to study drugs or...
- Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug/alcohol abuse within 6 months.
The study team makes the final eligibility decision.
Where it's taking place
- Sofia, Sofia, Bulgaria
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Poznan, Greater Poland Voivodeship, Poland
- Krakow, Lesser Poland Voivodeship, Poland
- Tarnów, Lesser Poland Voivodeship, Poland
- Wroclaw, Lower Silesian Voivodeship, Poland
- Lublin, Lublin Voivodeship, Poland
- Opole, Opolskie Voivodeship, Poland
- Bialystok, Podlaskie Voivodeship, Poland
- Katowice, Silesian Voivodeship, Poland
- Gyeonggi-do, Bundang-gu, South Korea
- Daegu, Dalseo-gu, South Korea
- Gyeonggi-do, Danwon-gu, South Korea
- Seoul, Dongjak-gu, South Korea
- Yangsan, Gyeongsangnam-do, South Korea
- Incheon, Incheon, South Korea
- Seoul, Seocho-gu, South Korea
- Seoul, Seodaemun-gu, South Korea
- Seoul, Seoul, South Korea
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sofia, Sofia, Bulgaria; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Poznan, Greater Poland Voivodeship, Poland; Krakow, Lesser Poland Voivodeship, Poland; Tarnów, Lesser Poland Voivodeship, Poland and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.