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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Clinical Project Manager
- 電話番号：+86-021-51371305
- メール：xiaofeng.cai@mabgeek.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Urticaria Activity Score over 7 Days (UAS7) at Week 16
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Itch Severity Score over 7 Days (ISS7) at Week 16
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
adverse events
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Jianzhong Zhang, MD、Peking University People's Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。