Evaluating JYB1904 for Chronic Spontaneous Urticaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II trial aims to assess the efficacy, safety, and tolerability of JYB1904 injection in adults suffering from Chronic Spontaneous Urticaria (CSU) that has not been adequately controlled by standard antihistamines. Participants must have experienced symptoms such as itching and hives for at least six weeks prior to the screening visit. The study will compare the effects of JYB1904 against a known treatment, Omalizumab, to determine its potential benefits for managing CSU symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female adult subjects (≥18 years of age).
* Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
* Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.
* Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.

Exclusion Criteria:

* Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria
* Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results
* Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
* Previous allergic reaction or poor efficacy with omalizumab.
* Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yila Sha
• Email: shayila@jemincare.com
• Phone: 86-021-52887926

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

  This trial tests a sequencing plan using remibrutinib and omalizumab to see if it helps adults with chronic spontaneous urticaria that isn’t well controlled by second-generation antihistamines.

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• BBT001 in adults with chronic spontaneous urticaria

  This trial tests whether BBT001 given by IV is safe and can help reduce urticaria in adults who have chronic spontaneous hives.

  Recruiting Phase 1/2 Bambusa Therapeutics · Wuhu, Anhui and 9 other locations · NCT07717905

• Remibrutinib in real-world care for Chronic Spontaneous Urticaria in Germany

  This study looks at how well and how safely remibrutinib works for adults with chronic spontaneous urticaria in real clinical practice after doctors decide to switch or escalate treatment.

  Recruiting Novartis · Düren · NCT07642557

• Testing single and multiple oral doses of EDP-978 in healthy adults

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• Remibrutinib for adults with chronic spontaneous urticaria in routine care

  This prospective US study will see if remibrutinib helps adults with chronic spontaneous urticaria in real-world clinical practice using patient-reported outcome questionnaires.

  Recruiting Novartis · East Hanover, New Jersey · NCT07408219

• JYB1904 Injection for Chronic Spontaneous Urticaria in Adults

  This trial tests whether JYB1904 injections help adults with chronic spontaneous hives that aren’t well controlled by standard antihistamines.

  Recruiting Phase 3 Jemincare · Beijing · NCT07402213

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.