A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
A Phase 2b, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Active Noninfectious Intermediate, Posterior, or Panuveitis
This trial will help researchers learn if tulisokibart, the trial medicine, can treat non-infectious intermediate, posterior, or panuveitis (NIIPPU) so that steroids can be given for a shorter period of time. In this trial, researchers will look at different doses (amounts) of tulisokibart.
The goal of this trial is to learn if tulisokibart works better than placebo to increase the length of time until NIIPPU gets worse. A placebo looks like the trial medicine but has no medicine in it. Using a placebo helps researchers better understand the effects of the trial medicine.
調査の概要
状態
詳細な説明
This study consists of a 50-week Double-blind Period and a 134-week Long-term Extension.
研究の種類
入学 (推定)
段階
- フェーズ2
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:
The main inclusion criteria include but are not limited to the following:
- Has active noninfectious intermediate uveitis, posterior uveitis, or panuveitis (NIIPPU) at screening and baseline in at least one eye
- Meets prior stable dose and duration requirements before baseline for permitted immunosuppressive therapies and corticosteroids
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has isolated anterior uveitis
- Has macular edema as the only sign of intermediate, posterior, or panuveitis
- Has active ocular disease that may confound assessment or is not adequately controlled
- Has significant ocular comorbidity that would interfere with visualization or study assessments
- Has planned ocular surgery during the double-masked treatment period
- Has had recent ocular surgery or ocular laser procedure that could affect study assessments
- Has had major surgery within 3 months prior to Screening or has major surgery planned during the study
- Has a contraindication to mydriatic eye drops or cannot be adequately dilated for fundus - visualization
- Has any condition preventing evaluation of both eyes for eligibility or efficacy assessments
- Has any other immune-mediated inflammatory condition that is not well controlled and may require prohibited therapy
- Has a transplanted organ requiring continued systemic immunosuppression
- Has active infection
- Has a recent history of malignancy that is not considered adequately resolved
- Has had a recent diagnostic evaluation for malignancy where malignancy cannot be reasonably excluded
- Has demonstrated intolerance to or prior inadequate response to high-dose oral corticosteroids for the study indication
- Has known allergies, hypersensitivity, or intolerance to the study drug and other medications, dyes
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Tulisokibart Low Dose
Participants receive background therapy of prednisone plus a high dose of tulisokibart. |
Subcutaneous (SC) administration
他の名前：
Oral administration |
|
実験的：Tulisokibart High Dose
Participants receive background therapy of prednisone plus a low dose of tulisokibart. |
Subcutaneous (SC) administration
他の名前：
Oral administration |
|
プラセボコンパレーター：Placebo
Participants receive background therapy of prednisone plus placebo to tulisokibart. |
SC administration Oral administration |
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 |
|---|---|---|
|
Time to Treatment Failure Occurring on or After Week 6 Through Week 50
時間枠：up to 44 weeks
|
The time to treatment failure is the interval from the date of first study dose intervention to the earliest assessment date on which any protocol-specified treatment failure criterion is met. The time to treatment failure occurring on or after Week 6 through Week 50 will be reported. |
up to 44 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants with Treatment Failure Occurring on or After Week 6 Through Week 26
時間枠：Up to 20 weeks
|
The time to treatment failure is the interval from the date of first study dose intervention to the earliest assessment date on which any protocol-specified treatment failure criterion is mat. The percentage of participants with treatment failure treatment failure occurring on or after Week 6 through Week 26 will be reported. |
Up to 20 weeks
|
|
Mean Change in Vitreous Haze (VH) Grade from Best State Achieved Prior to Week 6 up to Week 50
時間枠：Baseline and up to Week 50
|
VH Grade will be assessed by dilated indirect ophthalmoscopy in accordance with the National Eye Institute/ Standardization of Uveitis Nomenclature criteria with grades ranging from 0 (no evident vitreal haze) to 4+ (optic nerve head is obscured) with a higher grade indicating a greater amount of VH. The mean change in VH grade from best state achieved prior to Week 6 up to Week 50 will be reported. |
Baseline and up to Week 50
|
|
Mean Change in Logarithm of the Minimal Angle of Resolution Best Corrected Visual Acuity (BCVA) from Best State Achieved Prior to Week 6 up to Week 26
時間枠：Baseline and up to Week 26
|
Refraction will be performed in the participant's study eye, and using the appropriate corrective lenses, BRCA will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The BCVA scores will be converted to a log scale and reported as the logarithm of the minimal angle of resolution (logMAR) BCVA. The mean change from best state achieved prior to Week 6 up to Week 26 will be reported. |
Baseline and up to Week 26
|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
時間枠：Up to 198 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported. |
Up to 198 weeks
|
|
Number of Participants Who Discontinue Study Intervention Due to an AE
時間枠：Up to 184 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported. |
Up to 184 weeks
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
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
本研究に関する用語
その他の研究ID番号
- 7240-019
- 2025 (米国 NIH グラント/契約)
- U1111-1329-4205 (レジストリ識別子：UTN)
- 2025-524059-30-00 (レジストリ識別子：EU CT)
- MK-7240-019 (その他の識別子：MSD)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。