Clinical Trials

Inclusion Criteria:

• Male or females aged 18 to 75 years, inclusive at the time of informed consent.
• Confirmed diagnosis of pulmonary sarcoidosis for at least 6 months (cutaneous and ocular involvement permitted), defined by the following criteria:
  • Documented histologically proven diagnosis of sarcoidosis by tissue biopsy (any organ);
  • Documented evidence of parenchymal lung involvement by historical radiological evidence (eg, computed tomography [CT], magnetic resonance imaging [MRI], fluorodeoxyglucose positron emission tomography [18F-FDG]/CT or chest X-ray; or on screening high-resolution CT).
• Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria:
  • Modified medical research council (MRC) dyspnea scale grade of at least 1 (and remain stable between screening and baseline);
  • KSQ-Lung score ≤ 70.
• Patients must be receiving treatment with OCS (prednisone or equivalent) and fulfill the following criteria:
  • Treatment of ≥ 3 months;
  • Starting dose between ≥ 7.5 and ≤ 25 mg/day;
  • Stable dose for ≥ 4 weeks prior to Day 1;
  • Willing to attempt OCS taper to 0 mg/day.
• Body weight ≥ 40 kg and < 160 kg.
• If female of childbearing potential, must:
  • Not be pregnant or lactating, and have a negative pregnancy test at Screening (serum) and at Day 1 (urine) prior to first study drug infusion;
  • Be willing to use acceptable contraception from Screening until 8 weeks after the last study drug administration;
  • Note: To be considered of non-childbearing potential, the patient must be either surgically sterile or postmenopausal (confirmed by amenorrhea duration of at least 12 months with no alternative medical cause.
• Provide written informed consent.
• Agree to comply with all study procedures and requirements.  

Exclusion Criteria: 

• Current disease presentation consistent with Lofgren’s syndrome (i.e., presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest X-ray, and joint pain).
• Treatment with > 1 oral immunosuppressant therapy (e.g., methotrexate, leflunomide).
• Treatment (within 4 months of Day 1) with biological immunomodulators, such as TNF-α inhibitors (eg, infliximab, adalimumab) or antifibrotics (pirfenidone, nintedanib) or interleukin inhibitors (e.g., canakinumab, ustekinumab).
• Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following:
  • High resolution CT fibrosis > 20% at Screening;
  • FVC % predicted < 50%;
  • KSQ-Lung score < 30.
• Clinically significant bronchiectasis or cavitary sarcoidosis with mycetoma at Screening or during the previous 12 months.
• Clinically significant pulmonary hypertension requiring treatment with vasodilators.
• Patients with cardiac sarcoidosis (inclusive of but not limited to active inflammation with low ejection fraction, presence of arrhythmias), neurosarcoidosis, or renal sarcoidosis.
• Clinically significant cutaneous and ocular sarcoidosis.
• History of Addisonian symptoms that precluded previous OCS taper attempts.
• History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to efzofitimod or its inactive components (L-histidine, sodium chloride, sucrose, L-methionine, and polysorbate-20).
• In the opinion of the Investigator and Medical Monitor, current evidence of clinically significant cardiovascular, hepatic, neurological, renal, hematological, lymphatic, metabolic, or gastrointestinal disease, or any condition that requires other treatment or surgery, that may preclude the assessment of efficacy, confound the assessment of safety, or compromise patients compliance with study procedures.
• Active or history of malignancy within the last 5 years, except for  in situ carcinoma of the cervix, breast or stomach; or effectively managed stage 1 prostate carcinoma. 
• An exception is also made for history of other malignancies considered by the investigator to be cured, have no recurrence within 5 years of screening, and not requiring ongoing therapy.
• Major surgery or hospitalization within 3 months prior to Day 1 or anticipated surgery during the study.
• Participation in another clinical study of an investigational agent or device within 3 months (small molecules and device), 6 months (biologics), or 5 half-lives (if known) of the agent, whichever is longer.
• Is an active, heavy smoker of tobacco/nicotine-containing products (defined as > 20 cigarettes/day or e-cigarette equivalent).
• Active substance abuse (drugs, alcohol, or cannabis) or history of substance abuse within 12 months prior to Screening.
• Clinically significant abnormalities in the Screening physical examination, vital signs, ECG, or clinical laboratory test results that, in the opinion of the Investigator and Medical Monitor, preclude the patient’s participation in the clinical study.
• History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at baseline.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/25/23. Questions regarding updates should be directed to the study team contact.