Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
2026年6月10日 更新者：CONNEXT
A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants With Dupuytren's Contracture
This trial is a multicenter, Phase 1/2, study to assess the safety, tolerability, efficacy, PK, and immunogenicity of CNT201 in adult participants with DC (Dupuytren's Contracture).
調査の概要
状態
募集
詳細な説明
This is an adaptive clinical study design containing 2 steps:
- Step 1 (dose escalation) is an open-label, dose escalating design where each participant will be enrolled into 1 of 4 dose levels and receive a single administration of CNT201. A Safety Review Committee (SRC) will decide on the dose escalation steps and which dose(s) will be selected to progress into Step 2 dose expansion stage.
- Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design. Eligible participants will be randomized to receive either CNT201 or a placebo for up to a total of 3 treatment cycles per cord at the discretion of the Investigator.
研究の種類
介入
入学 (推定)
60
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Suntae Kim
- 電話番号：+82-10-5682-2489
- メール：suntae.kim@connext.co.kr
研究場所
-
-
Queensland
-
Kippa-Ring、Queensland、オーストラリア、4021
- 募集
- A R Houston Medical Pty Ltd.
-
コンタクト：
- Anthony R Houston, MD
-
主任研究者：
- Anthony R Houston, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Men and women, 18 to 75 years of age, inclusive.
- Participants with a diagnosis of DC, with a fixed flexion deformity of at least 1 finger, other than the thumb, that have a contracture at least 20°, but not greater than 100°, for MP (not greater than 80° for PIP) joints, caused by a palpable cord.
- Participants who have a positive Table Top Test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a tabletop.
- Participants who are naive to CNT201 treatment.
- Participants who are judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
- Participants who are willing to voluntarily sign and date the Informed Consent Form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Exclusion Criteria:
- Participants previously exposed to collagenase Clostridium histolyticum for treatment of Dupuytren's disease (Xiaflex, Xiapex®).
- Participants who have received other treatments for advanced Dupuytren's disease, including surgery (fasciectomy or fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study treatment.
- Participants with a chronic muscular, neurological, or neuromuscular disorder that affects the hands, or other medical condition which in the Investigator's opinion will make the participant unsuitable for enrollment in the study.
- Participants who have a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition (eg, testing positive for tuberculosis [TB] or Coronavirus disease 2019 [COVID-19], etc), or history of alcoholism or drug abuse, which in the Investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Participants who have a known allergic response to collagenase or any other excipient of CNT201 or Xiaflex.
- Participants who have received a doxycycline or tetracycline derivative within 14 days before the beginning of the study (tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs).
- Participants who have received an anticoagulant (except aspirin ≤150 mg/day) within 7 days before the start of the study.
- Female participants who are nursing or pregnant, or plan to become pregnant during the study treatment stage of the study.
- Participants who have been treated with any investigational drug within 30 days of first dose of study treatment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：[Step1] CNT201 First-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): First-dose |
|
実験的：[Step1] CNT201 Low-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Low-dose |
|
実験的：[Step1] CNT201 Intermediate-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose |
|
実験的：[Step1] CNT201 High-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): High-dose |
|
実験的：[Step2] CNT201
|
eligible participants will be randomized to 1 of 2 or more treatment arms, depending on the number of CNT201 doses selected for administration in Step 2
|
|
プラセボコンパレーター：[Step2] Placebo
|
• Saline
|
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 |
|---|---|---|
|
[Step 1] Incidence of adverse events
時間枠：Day 1 through Day 57
|
Adverse events including TEAEs, SAEs, and AESIs assessed by frequency and severity, coded using MedDRA and graded per CTCAE v5.0.
All adverse event types will be aggregated and reported as overall incidence of adverse events.
|
Day 1 through Day 57
|
|
[Step 1] Change from baseline in systolic and diastolic blood pressure
時間枠：Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in pulse rate
時間枠：Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in respiratory rate
時間枠：Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in body temperature
時間枠：Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in 12-lead ECG parameters
時間枠：Screening and Day 1 (1 hour post-dose)
|
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
|
Screening and Day 1 (1 hour post-dose)
|
|
[Step 1] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
時間枠：Screening and Day 57
|
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters.
The number of participants with clinically significant changes from baseline will be summarized.
|
Screening and Day 57
|
|
[Step 1] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
時間枠：Screening, Day 1 (pre-dose), Day29, and Day 57
|
Complete physical examinations were performed at scheduled visits.
Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
|
Screening, Day 1 (pre-dose), Day29, and Day 57
|
|
[Step 1] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension
時間枠：Within 29 days of study treatment injection
|
Finger joint contracture (MP and PIP joints) measured by goniometry.
|
Within 29 days of study treatment injection
|
|
[Step 2] Incidence of TEAEs, SAEs, and AESIs by severity
時間枠：Screening through Month 12
|
Frequency and severity of adverse events coded using MedDRA and graded per CTCAE v5.0.
|
Screening through Month 12
|
|
[Step 2] Change from baseline in systolic and diastolic blood pressure
時間枠：Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change from baseline in pulse rate
時間枠：Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] ] Change from baseline in respiratory rate
時間枠：Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change from baseline in body temperature
時間枠：Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change from Baseline in Electrocardiogram Parameters
時間枠：Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
|
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
|
Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
|
|
[Step 2] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
時間枠：Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
|
Complete physical examinations were performed at scheduled visits.
Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
|
Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
|
|
[Step 2] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
時間枠：Screening through Week 52
|
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters.
The number of participants with clinically significant changes from baseline will be summarized.
|
Screening through Week 52
|
|
[Step 2] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension within 29 days after the first injection
時間枠：Within 29 days after first injection
|
Finger joint contracture (MP and PIP joints) measured by goniometry.
|
Within 29 days after first injection
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
時間枠：Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Assessed by finger goniometry at each scheduled visit.
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Mean percent change in degree of contracture
時間枠：Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Time to clinical success (contracture ≤5°)
時間枠：Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Defined as the first study day on which treated joint contracture is ≤5°.
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change in range of motion (full extension, full flexion, and total arc)
時間枠：Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Participant Global Assessment of Treatment Satisfaction Score
時間枠：Screening, Day 29, and Day 57
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29, and Day 57
|
|
[Step 1] Physician Global Assessment of Disease Severity Score
時間枠：Screening, Day 29, and Day 57
|
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe).
Higher scores indicate greater severity.
|
Screening, Day 29, and Day 57
|
|
[Step 1] Physician Global Assessment of Treatment Satisfaction Score
時間枠：Screening, Day 29, and Day 57
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29, and Day 57
|
|
[Step 1] Peak plasma concentration (Cmax) of CNXT1 and CNXT2
時間枠：Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Time to peak plasma concentration (tmax) of CNXT1 and CNXT2
時間枠：Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Area under the plasma concentration-time curve (AUC) of CNXT1 and CNXT2
時間枠：Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Half-life (t½) of CNXT1 and CNXT2
時間枠：Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Clearance (CL) of CNXT1 and CNXT2
時間枠：Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Volume of distribution (Vd/F) of CNXT1 and CNXT2
時間枠：Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Incidence of anti-drug antibodies against CNXT1 and CNXT2
時間枠：Day 1 (pre-dose), Day 15, 29, and Day 57
|
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
|
Day 1 (pre-dose), Day 15, 29, and Day 57
|
|
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension at Day 85 after first injection
時間枠：Day 85 after first injection
|
Assessed by finger goniometry.
|
Day 85 after first injection
|
|
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension within 29 days after the last injection
時間枠：Within 29 days after last injection
|
Assessed by finger goniometry.
|
Within 29 days after last injection
|
|
[Step 2] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
時間枠：Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Assessed by finger goniometry at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Mean percent change in degree of contracture
時間枠：Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Time to clinical success (contracture ≤5°)
時間枠：Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Defined as the first study day on which treated joint contracture is ≤5°.
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change in range of motion (full extension, full flexion, and total arc)
時間枠：Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Participant Global Assessment of Treatment Satisfaction Score
時間枠：Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Physician Global Assessment of Disease Severity Score
時間枠：Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe).
Higher scores indicate greater severity.
|
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Physician Global Assessment of Treatment Satisfaction Score
時間枠：Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Time to recurrence
時間枠：Month 2, 3, 4, 6, 9, and Month 12
|
Defined as an increase in joint contracture to ≥20° in the presence of a palpable cord.
|
Month 2, 3, 4, 6, 9, and Month 12
|
|
[Step 2] Proportion of participants with contracture recurrence at Month 12
時間枠：Month 12
|
Recurrence defined as joint contracture ≥20° in the presence of a palpable cord.
|
Month 12
|
|
[Step 2] Incidence of anti-drug antibodies against CNXT1 and CNXT2
時間枠：Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
|
Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年7月23日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年7月25日
試験登録日
最初に提出
2024年8月23日
QC基準を満たした最初の提出物
2026年6月5日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月10日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- DC2201
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?
未定
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
はい
米国FDA規制機器製品の研究
いいえ
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