Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT03824392
Eligibility Criteria:
Key Inclusion Criteria:
* Diagnosis of pulmonary sarcoidosis for ≥6 months (cutaneous and ocular involvement allowed), defined as:
* Histologically proven diagnosis of sarcoidosis by bronchoscopy, biopsy (any organ) or bronchioalveolar lavage
* Parenchymal lung involvement by historical radiological evidence
* Must have symptomatic and/or active pulmonary sarcoidosis as evidenced by:
* Modified Medical Research Council Dyspnea Scale grade of \>= 1; and
* Forced vital capacity ≥50%; and
* Receiving treatment with 10 to 25 mg/day of oral prednisone (or equivalent), at a stable dose for ≥4 weeks prior to Day 1, and capable of undergoing the protocol-specified steroid taper regimen.
* Body weight ≥45 kg and \<160 kg.
Key Exclusion Criteria:
* Current disease presentation consistent with Lofgren's syndrome.
* History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to efzofitimod or to its inactive components (L-histidine, sodium chloride, sucrose, L-methionine, and polysorbate-20).
* Treatment with biological immunomodulators such as tumor necrosis factor-alpha inhibitors.
* Current evidence of clinically significant cardiovascular, hepatic, renal, hematological, metabolic, or gastrointestinal disease, or has a condition that requires other treatment.
* Clinically significant pulmonary hypertension requiring vasodilator treatment.
* Any history of tuberculosis or evidence of active systemic non-tuberculosis fungal or mycobacterial infection within 1 year of Screening.
* History of clinically significant cardiac, neurological, gastrointestinal, and/or renal manifestations of sarcoidosis.
* Any condition that necessitated hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.
* Participation in another clinical study of an investigational agent or device within 3 months (small molecules) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.
* History of or positive results of screening for hepatitis B, hepatitis C or human immunodeficiency virus.
* Is an active, heavy smoker of tobacco/nicotine-containing products (defined as \>20 cigarettes/day or e-cigarette equivalent).
* Active substance abuse or history of substance abuse within the 12 months prior to Screening.
* Participant has received a live vaccination within 8 weeks before Day 1 or inoculation with a live vaccine is planned during study participation.
* Positive for Jo-1 antibodies (Ab) at Screening, or past history of Jo-1 Ab positivity.
* Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03824392
Study Brief:
Protocol Section:
NCT03824392