A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis (ATMOS)
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis (ATMOS)
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:UCB Cares
- 電話番号:1-844-599-2273 (USA)
- メール:ucbcares@ucb.com
研究連絡先のバックアップ
- 名前:UCB Cares
- 電話番号:0018445992273
- メール:ucbcares@ucb.com
参加基準
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
説明
Inclusion Criteria:
- Participant must be 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF)
- Participant with a documented history of Non-Cystic Fibrosis Bronchiectasis (NCFB) (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by high resolution computed tomography (HRCT) demonstrating bronchiectasis in 1 or more lobes. Confirmation of diagnosis via HRCT will be performed as close as possible to, and within 7 calendar days of the Baseline visit, in all participants who meet all inclusion criteria and no exclusion criteria at Screening. Central reading confirmation, where images are evaluated by independent centralized experts, is required before the participant is randomized
- Participant with a history of chronic expectoration who are current sputum producers and are able to provide spontaneous sputum sample at Screening. If the participant is unable to produce spontaneous sputum at Screening, the participant will be considered a screening failure and may be rescreened once
- Participant with a history of at least 2 moderate or severe pulmonary exacerbations within the past 12 months prior to Screening or 1 severe pulmonary exacerbation within 6 months prior to Screening
- Participant with post- Bronchodilator (BD) forced expiratory volume (FEV) 1% predicted ≥30% at Screening and Baseline
- Participant has acceptable inhaler (where applicable) and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit. Participants who do not meet such criteria can be repeated once without being rescreened
Participant can be male or female
- A male participant must agree to use contraception during the Intervention Period and for at least 60 days after the final dose of study intervention, and refrain from donating sperm during this period
A female participant is eligible to[ participate if she is not pregnant, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the Intervention Period and for at least 60 days after the final dose of study intervention
Exclusion Criteria:
- Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or Electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has a presence or family history (first degree) of inflammatory bowel disease (IBD) (includes Crohn's disease and ulcerative colitis)
- Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within 6 months prior to the Baseline, as judged by the investigator.
Participant is not permitted to enroll into the study if they meet any of the following Tuberculosis (TB) exclusion criteria:
- Known active TB disease.
- History of active TB involving any organ system unless adequately treated according to World Health Organization/Centers for Disease Control and Prevention therapeutic guidance and proven to be fully recovered upon consultation with an appropriate relevant specialist
- Latent tuberculosis infection (LTBI) (unless a course of appropriate preventative therapy has been completed prior to study intervention dosing). TB preventive therapy should be in accordance with applicable clinical guidelines and appropriate specialist judgment based on the origin of the infection
- High risk of acquiring TB infection
- Participant has clinically important pulmonary disease other than NCFB as judged by the investigator.
- Participant has an acute infection (including pulmonary infection) requiring antibiotics, systemic corticosteroids, or antiviral medication within 4 weeks prior to Screening (and in the Screening Period) based on the final day of antibiotic/antiviral/systemic steroid treatment or hospitalization discharge date, whichever occurred later. A participant who suffers from a pulmonary exacerbation during the Screening Period, prior to randomization, is considered a screen failure. Rescreening is allowed once following resolution of the pulmonary exacerbation
- Participant has bronchiectasis known to be due to lung fibrosis, cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency disorders or α1-antitrypsin deficiency
- Participant has a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma. A secondary diagnosis is allowed
- Participant has significant hemoptysis defined as ≥300mL or requiring blood transfusion within 6 weeks from Screening
- Participant has a history of lung transplantation
- Study participant has an absolute neutrophil count (ANC) <1.5×103/μL. This test can be repeated once
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:Galvokimig Dose 1 Arm
Participants randomly assigned to this arm will receive Galvokimig Dose 1
|
薬剤: ガルボキミグ 製剤: 注射用溶液
他の名前:
|
|
実験的:Galvokimig Dose 2 Arm
Participants randomly assigned to this arm will receive Galvokimig Dose 2
|
薬剤: ガルボキミグ 製剤: 注射用溶液
他の名前:
|
|
実験的:Galvokimig Dose 3 Arm
Participants randomly assigned to this arm will receive Galvokimig Dose 3
|
薬剤: ガルボキミグ 製剤: 注射用溶液
他の名前:
|
|
プラセボコンパレーター:Placebo Arm
Participants randomly assigned to this arm will receive a matching Placebo.
|
Drug: Placebo Pharmaceutical form: Solution for injection
|
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 from intervention assignment to first moderate or severe pulmonary exacerbation
時間枠:Up to Week 52
|
A moderate pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe oral antibiotics (with or without oral corticosteroids): Increased cough, Increased, sputum volume or change in sputum consistency, Increased sputum purulence, Increased breathlessness and/or decreased exercise tolerance, Fatigue and/or malaise, Hemoptysis.
A severe pulmonary exacerbation in this study is defined as an exacerbation requiring iv antibiotics and/or hospitalization.
|
Up to Week 52
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Annualized rate of pulmonary exacerbations
時間枠:Up to Week 52
|
A moderate pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe oral antibiotics (with or without oral corticosteroids): Increased cough, Increased, sputum volume or change in sputum consistency, Increased sputum purulence, Increased breathlessness and/or decreased exercise tolerance, Fatigue and/or malaise, Hemoptysis.
A severe pulmonary exacerbation in this study is defined as an exacerbation requiring iv antibiotics and/or hospitalization.
|
Up to Week 52
|
|
Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24
時間枠:At Week 24
|
Lung function will be measured by centrally provided spirometry equipment.
Spirometry at clinical site visits should be performed in accordance with the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Post-BD spirometry should be performed consistent with the mechanism of action of reliever (ie, 30 minutes [±5 minutes] following 4 puffs of 100μg/puff of salbutamol or albuterol).
Three measurements fulfilling the ATS/ERS acceptability and repeatability criteria should be obtained at every spirometry visit.
|
At Week 24
|
|
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
時間枠:Up to Week 60
|
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.
A TEAE is defined as any AE with a start on or after the first administration of study intervention.
|
Up to Week 60
|
|
Incidence of TE Serious Adverse Events (SAEs)
時間枠:Up to Week 60
|
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above. |
Up to Week 60
|
|
Change from Baseline in Quality of life questionnaire-bronchiectasis (QOL-B) Respiratory Symptoms Domain Scores at Week 24
時間枠:At Week 24
|
The QOL-B is a disease-specific, PRO designed to assess symptoms, functioning, and health related quality of life in adults with bronchiectasis.
It comprises 37 items grouped into 8 domains.
Items use 4-point Likert-type response options, with recall periods typically referencing the previous week.
Each domain is scored separately and standardized to a 0-100 scale, where higher scores indicate better health status; no total score is calculated.
|
At Week 24
|
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
キーワード
その他の研究ID番号
- NCFB01
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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。