A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Chronic Spontaneous Urticaria
This Phase 2 study evaluates the efficacy and safety of MG-K10 in participants with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines. Participants are randomized 1:1 to MG-K10 or placebo for 16 weeks, followed by an 8-week follow-up period.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Clinical Project Manager
- Telefonnummer: +86-021-51371305
- E-post: xiaofeng.cai@mabgeek.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- CSU diagnosed ≥6 months.
- Itch and hives present continuously for >6 weeks despite second-generation H1-antihistamine treatment.
- Before randomization：UAS7 ≥16，ISS7 ≥8，at least one investigator-assessed UAS ≥4.
- Stable second-generation H1-antihistamine background therapy per protocol.
- Effective contraception requirements during study and for 6 months after last dose.
Exclusion Criteria:
- Chronic inducible urticaria or other urticaria/angioedema-mimicking diseases.
- Other chronic pruritic skin disease affecting assessment.
- Active or inadequately treated tuberculosis；acute/subacute infection.
- Clinically significant uncontrolled diabetes，cardiac，renal，hepatic，neurologic，autoimmune，or other severe systemic disease.
- Hypersensitivity to study drug/excipients；severe monoclonal-antibody reaction history.
- Prior MG-K10 trial participation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: MG-K10；600 mg SC at Week 0, then 300 mg SC Q4W through Week 12，4 doses total.
|
MG-K10 humanized monoclonal antibody injection targeting interleukin-4 receptor alpha (IL-4Rα), administered by subcutaneous injection. |
|
Placebo komparator: Matching placebo SC；4.0 mL at Week 0, then 2.0 mL Q4W，4 doses total.
|
Matching placebo administered by subcutaneous injection, placebo matches MG-K10 in appearance and administration schedule to maintain blinding. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16
Tidsramme: Baseline to Week 16
|
UAS7 is the sum of daily itch severity and hive severity scores over 7 days, with total scores ranging from 0 to 42. The change from baseline at Week 16 will be compared between MG-K10 and placebo. |
Baseline to Week 16
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Itch Severity Score over 7 Days (ISS7) at Week 16
Tidsramme: Baseline to Week 16
|
The Itch Severity Score over 7 Days (ISS7) is the sum of the daily itch severity scores over 7 consecutive days. Each daily itch severity score ranges from 0 to 3, where 0 indicates no itch and 3 indicates intense itch. The total ISS7 ranges from 0 to 21, where 0 indicates no itch and 21 indicates the most severe itch. Higher ISS7 scores indicate worse itch severity. Change from baseline is calculated as the ISS7 at Week 16 minus the baseline ISS7; a negative change indicates improvement. |
Baseline to Week 16
|
|
Change from baseline in Hives Severity Score over 7 Days (HSS7) at Week 16
Tidsramme: Baseline to Week 16
|
The Hives Severity Score over 7 Days (HSS7) is the sum of the daily hives severity scores over 7 consecutive days. Each daily hives severity score ranges from 0 to 3, where 0 indicates no hives, 1 indicates fewer than 20 hives per 24 hours, 2 indicates 20 to 50 hives per 24 hours, and 3 indicates more than 50 hives per 24 hours or large confluent areas of hives. The total HSS7 ranges from 0 to 21. Higher HSS7 scores indicate greater hives severity and worse outcome. Change from baseline is calculated as the HSS7 at Week 16 minus the baseline HSS7; a negative change indicates improvement. |
Baseline to Week 16
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
adverse events
Tidsramme: Baseline to Week 24
|
Adverse events will be assessed from the first administration of study intervention through the protocol-specified follow-up period. The number of participants experiencing at least one adverse event will be summarized by treatment group. |
Baseline to Week 24
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jianzhong Zhang, MD, Peking University People's Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MG-K10-CSU-002
Legemiddel- og utstyrsinformasjon, studiedokumenter
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