Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
NCT ID: NCT06424470
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2024-06-25
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Stapokibart
Stapokibart Injection, subcutaneous injection (SC)
Stapokibart
Stapokibart Injection
Placebo
subcutaneous injection (SC)
Placebo
Placebo
Interventions
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Stapokibart
Stapokibart Injection
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 18 ≤ Age ≤ 75 years old.
* Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.
Exclusion Criteria
* With clinically significant diseases.
* With severe liver and kidney function damage at the screening.
* With malignant tumors within the first 5 years before the screening.
* Plan to undergo major surgical procedures during this study.
18 Years
75 Years
ALL
No
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xinghua Gao
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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The First Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Other Identifiers
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CM310-110201
Identifier Type: -
Identifier Source: org_study_id
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