Health TrialsbyHealthPanel

Trial of JYB1904 in Chronic Spontaneous Urticaria.

ConditionChronic Spontaneous Urticaria
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: JYB1904: Dose-1Experimental treatment 1 intervention
Group B: JYB1904: Dose-2Experimental treatment 1 intervention
Group C: OmalizumabActive comparator 1 intervention

Trial outcomes

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

Time frame
Baseline through 16 weeks

Secondary outcomes

1

Urticaria activity score used for 7 consecutive days(UAS7)

Change from baseline in UAS7 at weeks 4, 24 and 32.Score 0-42, UAS7=0 for complete remission

Time frame
Baseline through 32 weeks
2

Itch severity score used for 7 consecutive days(ISS7)

Change from baseline in itch severity score used for 7 consecutive days(ISS7) at weeks 4, 8, 12, 16, 24 and 32.Score 0-21, ISS7=0 for complete remission of itch

Time frame
Baseline through 32 weeks
3

Hive severity score used for 7 consecutive days (HSS7)

Change from baseline in hive severity score used for 7 consecutive days(HSS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-21, HSS7=0 for complete remission of hives

Time frame
Baseline through 32 weeks
4

Angioedema activity score used for 7 consecutive days(AAS7)

Change from baseline in angioedema activity score used for 7 consecutive days(AAS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-105, higher scores mean a worse outcome

Time frame
Baseline through 32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Source ClinicalTrials.gov
Apply now