Questions and Answers
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A: Review your lab kit inventory and kit expiration, at minimum, monthly. Order at least 4 weeks in advance
A: Guidance for calculating the pack-years is available in the CRF Completion Guidelines and Section 11.1.2 of Protocol Version 2.1 and above
A: Yes, please include them as a budget line item
A: Per Section 7.4 of the Protocol, re-screening to meet inclusion criteria is possible. Please reach out to the Medical Monitor for discussion
A: Per footnote t and section 10.3, post-BD spirometry should be performed if the participant’s condition allows. Make every effort to obtain spirometry; however, it is not a protocol deviation if the participant cannot complete the assessment.
A: Only participants who enroll while in stable condition (channel 1) must have current or historical evidence of airflow obstruction. Participants who enroll through channel 2 are not required to meet this criterion. Please note this criterion was moved from Inclusion #4 to Inclusion #6 with protocol amendment 2.0 to clarify this distinction.
A: Yes it still applies, the participant should be excluded. This includes all systemic routes of administration (oral, SC, IM, IV) but not topical or nasal.
A: YES! Lab kit shipping may take longer than usual and couriers may be impacted. Please review your lab kit stock (including expiration date), place reorders, and communicate any potential schedule deviations to your CRA as soon as possible.
A: For hospitalized participants only, investigators or their designees will assess participants daily during the initial hospitalization against the site’s standard discharge criteria based on clinical assessment (e.g., normalization of acidosis, symptoms returning to manageable levels, physical exam). The date and time the participant is ready for discharge based on clinical assessment and venous blood gas results should be recorded.
A: Acute COPD exacerbations are an efficacy endpoint in the study. All participants must have had at least a moderate COPD exacerbation (i.e., requiring systemic steroids) to enter the trial. Section 11.3.1 of the protocol states the expected progression, signs, or symptoms of the disease or disorder being studied should not be recorded as an AE unless they become more severe or occur with a greater frequency than expected for the participant’s condition. Therefore, all COPD exacerbations should not be listed as an adverse event. A severe COPD exacerbation would generally qualify as a Serious Adverse Event since they are defined per protocol Section 10.2 to have “resulted in hospitalization or observation for over 24 hours in an ED or urgent healthcare facility”.
A: It is not recommended to use SAMAs as rescue medication during the trial period but may be used in exceptional circumstances such as for managing a COPD exacerbation event at the discretion of the Investigator. See Section 8.2.1 of the protocol.
A: Yes, for channel 1 (stable condition) participants, this will be clarified in the recently published protocol amendment version 3.0.
A: Visit 3 and Visit 4 are required for participants who are hospitalized. For participants who are not hospitalized, these visits are highly encouraged but not mandatory.
A: Fever recorded as >38°C and/or a suspected pulmonary infection are excluded, however there is no specific exclusion for upper respiratory infections in the absence of fever. Eligibility for patients with an upper respiratory infection without fever should be determined at the investigator’s discretion, based on the severity of symptoms and the patient’s underlying clinical status.
A: 1 - Fever and infection-related symptoms can mimic or overlap with adverse events (e.g., systemic responses).
2 - Fever often indicates an active infection (viral or bacterial), and biologics like rademikibart, which modulate the immune system by blocking IL-4Rα—a key component in type 2 inflammatory pathways—may alter immune response. It has not been investigated whether dosing during an active infection could impair immune defense or worsen the infection.
3 - Dosing a febrile patient could increase medical risk.
A: No, inclusion #6 (eosinophil count ≥250 cells/μL and/or FeNO ≥25 ppb, and post-BD FEV1/FVC ≤70%) only applies for participants who consent in stable condition via channel 1. However, all participants must meet inclusion #11 (eosinophil count ≥300 cells/μL) at Visit 1b to be eligible.
A: For hospitalized participants, venous blood gas (VBG) is the specified assessment in the protocol. Arterial blood gas (ABG) cannot be used as a substitute for VBG. VBG is not required for participants who are not hospitalized.
A: Section 10.3 provides the ideal sequence of assessments. However, during the Screening Visit (Visit 1b) and/or the Randomization Visit (Visit 2), this order may be modified as needed, including instances where some or all of these procedures are performed as part of routine/urgent/inpatient hospitalized care. Where possible at Visit 1b, it is advisable to obtain eosinophil count prior to the administration of corticosteroids if it does not compromise patient safety.
A: Please capture ALL vaped substances, including nicotine, cannabis, and flavorings. These individuals will still be considered smokers for the purposes of the study.
A: Given the variable nature of COPD exacerbations driven by type 2 inflammation, participants who initially are screen failures solely due to the ineligible eosinophil count (i.e., eosinophil count of <300 cells/µL) at Screening Visit 1b, are allowed to re-screen no more than twice if they experience another COPD exacerbation, provided it is deemed appropriate by the PI.
A: Yes, however this is a protocol deviation since BUN is required. The calculated BUN should be entered in EDC along with the calculated normal ranges.
A: Starting with Protocol Amendment 3, “approximately 12 months” includes a small allowance beyond 12 months—about 3–4 weeks. This means patients may still qualify if their COPD exacerbation (requiring systemic corticosteroids) occurred slightly more than 12 months before Screening, within this extended window.
A: Yes. While no new screening can be initiated after June 8, participants who were already in screening before this date may continue with assessments required to determine eligibility at Visit 1a. Participants already enrolled in Channel 1 can continue awaiting exacerbation until randomization has closed.
A: If the reason for Screen Failure was transient (e.g., a recent COPD exacerbation within 4 weeks prior to Screening, ineligible medication/vaccine washout at Screening, or clinically significant pneumonia identified by chest X-ray [CT scan] at Screening), then the participant may be re-screened after discussion with the Sponsor Medical Monitor/designee and documentation in the Investigator Study File.
The total number of screening chest X-rays and/or CT scans must not exceed 2. If re-screened, assign a new participant number, and the participant must meet all eligibility criteria at re-screening to enroll.