Trial of JYB1904 in Chronic Spontaneous Urticaria.

NCT06509334 | Recruiting Phase 2

• 1 other identifier: JYB1904-202
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (1)

• Urticaria activity score used for 7 consecutive days(UAS7)

  Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission

  Baseline through 16 weeks

Secondary Outcomes (9)

• Urticaria activity score used for 7 consecutive days(UAS7)

  Baseline through 32 weeks

• Itch severity score used for 7 consecutive days(ISS7)

  Baseline through 32 weeks

• Hive severity score used for 7 consecutive days (HSS7)

  Baseline through 32 weeks

• Angioedema activity score used for 7 consecutive days(AAS7)

  Baseline through 32 weeks

• Urticaria activity score used for 7 consecutive days(UAS7)

  Baseline through 32 weeks

Study Arms (3)

JYB1904: Dose-1

EXPERIMENTAL

Drug: JYB1904

JYB1904: Dose-2

EXPERIMENTAL

Drug: JYB1904

Omalizumab

ACTIVE COMPARATOR

Drug: Omalizumab

Interventions

JYB1904 DRUG

Participants will receive JYB1904 at week0 and receive placebo at week4,8,12

JYB1904: Dose-1

Omalizumab DRUG

Participants will receive Omalizumab every 4 weeks for 12 weeks

Omalizumab

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Yila Sha

CONTACT

86-021-52887926; shayila@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 19, 2024
• Study Start: August 4, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)