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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 3.1 and above
A: Yes, please include them as a budget line item so your Site may get reimbursed
A: Yes, you will need to provide evidence of current airflow limitation at visit 1a by performing pre- and post-bronchodilator spirometry and demonstrating airflow reversibility as outlined in Inclusion Criterion #7
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: Yes, up to 3 spirometry repeats are allowed at Visit 1a within two (2) weeks if a participant fails due to not meeting ATS standards. The investigator should be mindful of the participant’s tolerance to withholding inhaler pre-test, as indicated in the protocol, and verify that the washout period has been met before repeat testing (Section 10.3).
A: For hospitalized participants, Investigators will assess the participants daily during the initial hospitalization against the site’s standard discharge criteria based on clinical assessment and lung function tests (e.g., FEV1 or PEF has returned to ≥70 % of predicted or personal best and symptoms are minimal or absent). The time required to meet these criteria will be used to evaluate the speed of initial recovery from asthma exacerbation in hospitalized participants.
This assessment applies only to hospitalizations due to the initial asthma exacerbation and is not applicable to hospitalizations resulting from subsequent asthma exacerbations.A: Exclusion #2 “regular use of immunosuppressive medication 2 weeks or 5 half-lives prior to randomization” does still apply, the participant should be excluded. This includes all systemic routes of administration (oral, SC, IM, IV) but not topical or nasal.
A: Acute asthma exacerbations are an efficacy endpoint in the study. All participants must have had at least a moderate asthma 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 asthma exacerbations should not be listed as an adverse event.
A hospitalization or ED visit because of an asthma exacerbation, requiring systemic corticosteroids, would generally qualify as a Serious Adverse Event if more severe or occurs with a greater frequency than expected.
For those participants on OCS at the start of the trial, only a ≥2-fold increase in dosage in response to symptoms will fulfill the definition of exacerbation.A: Yes, for channel 1 (stable condition) participants, it is clarified in protocol version 4.0 that a peripheral blood eosinophil count of ≥250 cells/μL and/or a FeNO ≥25 ppb is required within 12 months prior to or at Screening Visit 1a.
A: The investigator should confirm and document the patient has asthma. If a patient reports having had asthma symptoms that have been treated for ≥12 months, a diagnosis documented in the medical records is not required to meet this inclusion criterion.
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: Yes. The timelines for withholding maintenance therapy outlined in protocol Section 10.3 apply to all study visits requiring pre-BD spirometry including Screening Visit 1a, unless explicitly contraindicated for patient safety. The mention in Footnote “t” of Visits 5, 6, 8, 9, and day of discharge (hospitalized participants) is intended to provide operational flexibility for participants recovering from an acute asthma exacerbation, where strict bronchodilator restrictions may not always be clinically appropriate. Visit 1a is for stable participants; therefore, withholding the maintenance therapy should not put the participant at risk. As a reminder, the Screening Visit 1a spirometry test may be repeated up to 3 times within 2 weeks.
A. Sites should enter a treatment failure when it happens, recording the first occurrence of each treatment failure type. As the study continues, the form should be updated as applicable. In other words, it is not a one-time use form. When the participant exits the study, please review the Treatment Failure form at End of Trial to make sure all information is accurate and up to date.
A: No. The ≥12‑month asthma history requirement is based on the initial physician diagnosis of asthma, as supported by medical records or patient report. A prior diagnosis in childhood satisfies this requirement even if symptoms resolved and asthma was later re‑diagnosed in adulthood. All other inclusion criteria must also be met.
A: Yes, however this is a protocol deviation since BUN is required. The calculated BUN should be entered in EDC.
A: Yes. Per protocol, a participant is eligible at Visit 1b only if the index asthma exacerbation required an urgent healthcare visit for treatment. This refers to the level of care needed, not a specific facility. For the purposes of this trial, an urgent healthcare setting may include an ED, a hospital inpatient ward, an urgent healthcare facility, or an outpatient clinic equipped to provide the protocol-specified level of care. If the participant’s index exacerbation required a visit in any of these settings, then this requirement is satisfied.
A: Starting with Protocol Version 4, “approximately 12 months” includes a small allowance beyond 12 months—about 3–4 weeks. This means patients may still qualify if their asthma 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: 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 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 request lab sample pickup ~48 hours in advance if possible. Refer to your site-specific “courier starterpack” for minimum advance notice requirements.
A: LabConnect “cancelled” laboratory tests refer to samples received out of stability or unusable for testing (example: hemolyzed). Please attempt to ship samples as soon as possible after collection and request pickup ahead of time. Refer to your courier starter pack
for proper shipping instructions. If the patient is willing to return, samples can be re-drawn at an unscheduled visit.
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