Trial of JYB1904 in Chronic Spontaneous Urticaria.

Sponsor
Jemincare
Study ID
NCT06509334
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JYB1904 — DRUG
    Participants will receive JYB1904 at week0 and receive placebo at week4,8,12
  • JYB1904 — DRUG
    Participants will receive JYB1904 at week0,8 and receive placebo at week4,12
  • Omalizumab — DRUG
    Participants will receive Omalizumab every 4 weeks for 12 weeks

Study Details

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

Key Dates

Start date
Aug 4, 2024
Status verified
Nov 2024
Primary completion
Jul 15, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JYB1904: Dose-1
  • Experimental: JYB1904: Dose-2
  • Active Comparator: Omalizumab

Primary Outcome Measure

Urticaria activity score used for 7 consecutive days(UAS7) [ Time Frame: Baseline through 16 weeks ]

Central Contacts

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