Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYB1904: Dose-1 | Experimental |
| |
| JYB1904: Dose-2 | Experimental |
| |
| Omalizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYB1904 | Drug | Participants will receive JYB1904 at week0 and receive placebo at week4,8,12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline through 32 weeks |
| Itch severity score used for 7 consecutive days(ISS7) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yila Sha | Contact | 86-021-52887926 | shayila@jemincare.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
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
| Baseline through 32 weeks |
| 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 | Baseline through 32 weeks |
| 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 | Baseline through 32 weeks |
| Urticaria activity score used for 7 consecutive days(UAS7) | Proportion of subjects with UAS7=0 at weeks 4, 8, 12, 16, 24, 32.Score 0-42, UAS7=0 for complete remission | Baseline through 32 weeks |
| Dermatology Life Quality Index(DLQI) | Change from baseline in Dermatological Life Quality Index (DLQI) at weeks 4, 8, 12, 16, 24 and 32.Score 0-30, higher scores mean a worse outcome | Baseline through 32 weeks |
| Safety and tolerability | Adverse events (AEs) and serious adverse events (SAEs) | Baseline through 32 weeks |
| Trends in serum total immunoglobulin E(IgE) | Serum total IgE levels at weeks 4, 8, 12, 16, 24 and 32 | Baseline through 32 weeks |
| Positive detection rate of anti-drug antibody (ADA) | ADA positive detection rate at 32 weeks | Baseline through 32 weeks |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |