רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT06445023 (EMBARQ-CSU1) עבור אורטיקריה ספונטנית כרונית הוא פעיל, לא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (EMBARQ-CSU1) שלב III 963
There is a screening period of up to 4 weeks, fol...
הצג עודA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)
- EMBARQ-CSU1
- CDX0159-12
- 2024-513208-32-00 (מספר ניסוי של האיחוד האירופי (CTIS))
barzolvolimab
chronic spontaneous urticaria
CSU
urticaria activity score
itch severity score
hives severity score
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיbarzolvolimab 150 mg barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks | barzolvolimab Subcutaneous Administration |
ניסיbarzolvolimab 300 mg barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks | barzolvolimab Subcutaneous Administration |
ניסיPlacebo then barzolvolimab 150 mg Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks. | barzolvolimab Subcutaneous Administration פלצבו תואם Matching placebo Subcutaneous Administration |
ניסיPlacebo then barzolvolimab 300 mg Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks. | barzolvolimab Subcutaneous Administration פלצבו תואם Matching placebo Subcutaneous Administration |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0. | From Day 1 (first dose) to Day 85 (Week 12) |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score) | The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The ISS7 is the itch severity score for 7 days, the scores range from 0 to 21. | From Day 1 (first dose) to Day 85 (Week 12) |
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score) | The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days, the scores range from 0 to 21. | From Day 1 (first dose) to Day 85 (Week 12) |
Percentage of participants with UAS7 = 0 at Week 12 | Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12. | From Day 1 (first dose) to Day 85 (Week 12) |
Percentage of participants with UAS7 ≤ 6 at Week 12 | Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7≤6) at Week 12. | From Day 1 (first dose) to Day 85 (Week 12) |
Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at Week 12 | Proportion of participants with AAS7 \> 0 at Day 1 who achieved complete control (AAS7 = 0) at Week 12
Angioedema Activity Score over 7 days \[AAS7\] describes the effect of angioedema on five categories with 0 being none and 3 being most severe. The final score is calculated by adding together daily scores which can range from 0-15 for 7 days. The resulting maximum score is then 105. | From Day 1 (first dose) to Day 85 (Week 12) |
Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12 | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) in participants who did not respond to or did not tolerate omalizumab.
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0. | From Day 1 (first dose) to Day 85 (Week 12) |
Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12 | Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12 in participants who did not respond to or did not tolerate omalizumab. | From Day 1 (first dose) to Day 85 (Week 12) |
Incidence of Treatment-Emergent Adverse Events | Occurrence of treatment emergent adverse events and serious adverse events during the study. | From Day 1 (first dose) to Day 477 (Week 68) |
Males and females, >/= 18 years of age.
Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1).
CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
- Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
- UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to study treatment.
Normal blood counts and liver function tests.
Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
Willing and able to complete a daily symptom electronic diary and comply with study visits.
Participants with and without prior biologic experience are eligible.
- Women who are pregnant or nursing.
- Chronic urticaria whose predominant manifestation is due to CIndU.
- Other diseases associated with urticaria.
- Active pruritic skin condition in addition to CSU.
- Medical condition that would cause additional risk or interfere with study procedures.
- Known HIV, hepatitis B or hepatitis C infection.
- Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
- History of anaphylaxis.
- Prior treatment with barzolvolimab.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Alabama
California
Colorado
Florida
Idaho
Illinois
Indiana
Kentucky
Louisiana
Maryland
Michigan
Missouri
Montana
Nevada
New Jersey
New York
Ohio
Oklahoma
Oregon
Pennsylvania
South Carolina
Texas
Utah
Washington
Buenos Aires
Buenos Aires F.D.
Sante Fe
Tucumán Province
Antwerpen
Vlaams Brabant
Alberta
Newfoundland and Labrador
Ontario
Rhone
Baden-Wurttemberg
Hesse
Lower Saxony
North Rhine-Westphalia
Schleswig-Holstein
Free State
Gauteng
KwaZulu-Natal
Western Cape
Seoul Teugbyesolsi
Barcelona