2024-518587-12-00招募中2 期
C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 318
- 试验地点
- 61
研究概览
简要总结
Phase 2: To assess the efficacy of 2 doses of PF-07275315 compared to placebo in participants with moderate-to-severe COPD Phase 3: To assess the efficacy of PF-07275315 compared to placebo in participants with moderate-to-severe COPD
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •35 to 80 years of age at Screening Visit
- •Individuals of childbearing potential must be willing to use a highly effective method of contraception. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- •Diagnosis of COPD for at least 1 year in accordance with the current GOLD definition.
- •Post-BD [FEV1]/ [FVC] ratio <0.7 and post-BD FEV1 ≥30% and ≤70% predicted. • Spirometry criteria need to be met on both pre-dose tests (Visits 1 and 3). • One repeat spirometry test (2 for Screening Visit 1) may be conducted for each visit within 7 days in case the participant forgot to withhold BD treatment for the required time before the visit, see Section 5.3.
- •CAT score ≥15 at least one time during Visits 1, 2 and 3 (pre-randomization). All CAT scores must be >10 to be eligible.
- •Blood eosinophil count ≥150 cells/µL (at least one of the Screening visits [Visit 1 or Visit 2]).
- •Continuous treatment with SOC therapy triple therapy of LABA + LAMA + ICS for ≥6 months prior to Screening Visit 1 and at a stable dose for ≥3 months prior to Screening Visit 1 LABA + LAMA double therapy is acceptable if ICS is contraindicated, country specific local ethical standards may apply.
- •Current or former smokers with a smoking history of ≥10 pack-years (based on the number of cigarettes). • Smoking includes the use of cigarettes (but not cigars only, pipes only, chewing tobacco, vaping, or zyn). • Former smokers are defined as those participants who have not smoked (used any tobacco product) for at least 6 months prior to Visit
- •Documented history of at least 2 moderate* or severe** ECOPD within the last 12 months prior to Visit
- •See Appendix 10 for more details. At least 1 of the 2 exacerbations needs to have been treated with systemic corticosteroids and 1 of the exacerbations must have occurred while the participant was taking triple therapy LABA+LAMA+ICS (unless ICS was contraindicated). * Moderate exacerbations are events of worsening COPD symptoms that require either systemic corticosteroids (such as intramuscular, or oral) and/or antibiotics with an effective duration of at least 3 days. **Severe exacerbations are events of worsening COPD symptoms that require hospitalization ≥24 hours or continuous treatment in an emergency department / urgent care facility for ≥24 hours.
- •BMI between 18 and 40 kg/m², inclusive.
排除标准
- •Evidence of extensive emphysema (documented clinical history or lung imaging [eg, Chest X-ray, high-resolution CT, MRI]) within 24 months of the Screening Visit
- •Extensive emphysema is defined quantitatively as approximately 25% or more of one hemithorax comprised of emphysematous bullae.
- •Any clinically significant conjunctivitis or other ocular surface changes.
- •Infection requiring systemic treatment with antivirals, antibacterials, antifungals, antiparasitics, or antiprotozoals within 4 weeks prior to Screening Visit
- •Any prior history of pneumonectomy or other lung resection (eg, wedge or lobectomy); lung volume reduction surgery within 12 months prior to Screening Visit 1 or planned during the study.
- •Initiation of a pulmonary rehabilitation program within 6 months of Screening Visit 1 or planned to be initiated during the study. Participants currently in the maintenance phase of a rehabilitation program are eligible.
- •Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation. Participants with persistent atrial fibrillation defined as continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (ie, selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) and a stable appropriate level of anticoagulation for at least 6 months; and participants with stable (not changing or transient) LAHB or LPHB may be considered for inclusion.
- •Clinically significant cardiovascular disease, acute and/or severe left heart failure, or HFpEF, and/or cor pulmonale.
- •Any clinically significant medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Prior or current use of any prohibited concomitant medication(s), or unwillingness or inability to use a required concomitant medication(s). Refer to Section 6.
- •For Phase 3 only: participants who had been enrolled or still enrolled in Phase 2 of this study whether or not they have completed Phase 2 or discontinued early from Phase
- •Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Rα, TSLP, IL-5) for other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS. Refer to Section 6.9 for details.
- •Significant chronic pulmonary disease other than COPD (this would include but not be limited to: lung fibrosis or other clinically significant interstitial lung disease (eg, scleroderma, RA, etc.); lung cancer; sarcoidosis; cystic fibrosis; extensive bronchiectasis, including or non-cystic fibrosis bronchiectasis; pulmonary hypertension; eosinophilic granulomatosis with polyangiitis; Churg-Strauss Syndrome; diagnosis of α-1 anti-trypsin deficiency) or any other diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. • Any history / diagnosis of asthma or asthma-COPD overlap syndrome.
- •History of anaphylaxis to an antibody therapeutic or to prior exposure of PF-07275315 or to the excipients of the formulated drug products.
- •Receipt of an investigational drug product (drug or vaccine) within 30 days or 5 half- lives preceding the Screening Visit 1 (whichever is longer). Note: Local regulations or other factors may require a washout period of more than 30 days.
- •Presence of any of the following laboratory abnormalities during Screening Period: • Total bilirubin ≥1.5 × ULN (for Gilbert’s syndrome, direct bilirubin > ULN is exclusionary) • AST or ALT ≥2.5 × ULN • ANC ≤1500 cells/mm³ • Platelets ≤100,000/mm³ • Hemoglobin ≤9.0 g/dL for females and ≤10.0 g/dL for males • Evidence of active or latent TB or inadequately treated infection with Mycobacterium TB. A participant who is currently being treated for active or latent TB infection must be excluded from this study. (see Section 8.3.6) • Active or latent HIV, hepatitis B, and/or hepatitis C (see Section 8.3.7)
- •Baseline standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST segment and/or T wave changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmia or tachyarrhythmia). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant’s eligibility, male and female values may be used. Computer-interpreted ECGs with abnormal findings should be overread by an investigator experienced in reading ECGs before excluding a participant. Refer to Section 8.3.3, and to Phase 2 SoA (Table 1) and Phase 3 SoA (Table 2).
- •Less than 4 out of 7 days (~57%) compliance with data entry completion of symptom diary and Rescue and Maintenance Medication Use Log during the Screening Period (Visits 1 through 3) may be considered exclusionary if deemed by the investigator as being indicative of a participant’s inability or unwillingness to comply with study- required procedures.
- •Investigator site staff directly involved in the conduct of the study and their family members, other site staff supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- •Individuals who are currently pregnant, breastfeeding, pregnant or planning to becaome pregnant during the study. Refer to Appendix 4 for IOCBP (Section 10.4.3) and contraception methods (Section 10.4.4).
- •Clinically significant PAH due to COPD.
- •Chronic respiratory failure associated with hypercapnia that requires noninvasive ventilatory support eg, BiPAP.
- •Requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula (or equivalent O2 delivery system, eg, face mask) for greater than 12 hours / day. Requirement for high flow / Venturi / non-rebreathing masks is exclusionary.
- •Hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant’s usual level of oxygen supplementation). Repeat at same visit is allowable to ensure proper technique and/or to address a potential medical event.
- •Clinically severe sleep apnea that requires BiPAP or is associated with evidence of clinically significant pulmonary hypertension.
- •Autoimmune / autoinflammatory diseases that require systemic immunosuppression or immunomodulators.
- •ECOPD, upper or lower respiratory infection, pneumonia, or hospitalization for COPD exacerbation for ≥24 hours duration within 4 weeks prior to Screening Visit 1.
研究组 & 干预措施
Placebo to PF-07275315
Placebo
干预措施: Placebo to PF-07275315 (Drug)
PF-07275315
Test
干预措施: PF-07275315 (Drug)
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (61)
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