An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
A Two-part, First-In-Human, Phase I, Open-label, Ascending Dose Study to Assess Safety and Tolerability of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this First-In-Human (FIH), Phase 1, open-label, ascending dose study is to determine safety and tolerability of DKB903, in participants with Rheumatoid Arthritis (RA) and participants with Systemic Lupus Erythematosus (SLE) in order to enable further clinical testing in these populations.
調査の概要
詳細な説明
This is a two-part, FIH, Phase 1, open-label, uncontrolled, ascending dose study designed to evaluate the safety and tolerability of DKB903, in participants with RA and participants with SLE.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Novartis Pharmaceuticals
- 電話番号:1-888-669-6682
- メール:novartis.email@novartis.com
研究連絡先のバックアップ
- 名前:Novartis Pharmaceuticals
- 電話番号:+41613241111
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
Key Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Able to communicate well with the Investigator, to understand the study and willing to comply with the requirements of the study.
- Immunization (primary or from vaccinations) against pneumococcus, influenza and COVID-19 at least 2 weeks prior to the first dosing.
- Male and female individuals, aged 18 to 75 years at screening, diagnosed with RA according to the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) or 1987 ACR classification at least 12 weeks prior to screening.
- Male and female individuals, aged 18 to 75 years at screening, diagnosed with SLE according to the 2019 ACR/EULAR criteria at least 12 weeks prior to screening.
Key Exclusion Criteria:
- Body weight < 45 kg or > 145 kg and Body Mass Index (BMI) < 16 or > 39.
- Use of prohibited medication or inadequate wash-out as per protocol.
- Protocol-defined cardiac conditions or clinically significant ECG abnormalities or arrhythmia.
- Clinically significant active, opportunistic, chronic or recurrent infection (including Human Immunodeficiency Virus [HIV], Hepatitis B [HBV], Hepatitis C [HBC], and Tubercolosis [TB]) confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA) within one month prior to or during screening.
- Serious medical illness likely to interfere with participation in this clinical study.
- Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) from the time of enrollment until weeks after last DKB903 administration.
Other protocol-defined inclusion/exclusion criteria may apply.
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:順次割り当て
- 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:Part A- Cohort A-DKB903
Participants will receive DKB903 at escalating dose levels. |
DKB903 |
|
実験的:Part B- Cohort B-DKB903 dose level identified as safe in Part A
DKB903 dose level identified as safe in Part A, plus up to two additional full doses. |
DKB903 |
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 |
|---|---|---|
|
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠:From Day 1 up to approximately 2 years.
|
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs. |
From Day 1 up to approximately 2 years.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence/absence of anti-drug antibodies (ADA) at baseline and over time
時間枠:Baseline, up to approximately 2 years.
|
To assess the Immunogenicity (IG) of DKB903 |
Baseline, up to approximately 2 years.
|
協力者と研究者
スポンサー
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
追加の関連 MeSH 用語
その他の研究ID番号
- CDKB903A02101
- 2026-526247-35-00 (その他の識別子:EU CT number)
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?
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
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