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. 2020 Apr 17;16:323–345. doi: 10.2147/TCRM.S192922

Table 4.

Ongoing Trials for Sarcoidosis

Indication Molecule on Trial Measured Outcomes Phase NCT Control Advancement
Cardiac sarcoidosis (CHASM-CS-RCT) Methotrexate + prednisone: Methotrexate 15–20 mg orally, SC, or IM once a week for 6 months + prednisone 20 mg daily for one month then 10 mg po daily for one month then 5 mg daily for one month and then stop. Also, Folic Acid 2 mg daily for 6 months. Summed perfusion rest score (SPRS) on FDG-PET scan, mortality, cardiovascular hospitalization 3 NCT03593759 Prednisone Recruiting
Cardiac sarcoidosis Anakinra (100 mg subcutaneous each day for 4 weeks) (MAGIC ART) Change in c-reactive protein in participant plasma samples, change in cardiac PET, change on cardiac MRI, number of serious cardiac events 2 NCT04017936 Placebo Not yet recruiting
Chronic pulmonary sarcoidosis Tranilast (0.1g each time, three times a day,12 months) Changes in the size of the pulmonary nodule by ultrasound, changes of the forced vital capacity (FVC) 1 NCT03528070 ND Not yet recruiting
Chronic pulmonary sarcoidosis with fibrosis Roflumilast Reduction in number of episodes of acute exacerbation, change in FVC, change in quality of life 4 NCT01830959 Placebo Unknown status
Pulmonary sarcoidosis Azithromycin (250 mg/d 3 months) 24h cough monitoring with ambulatory cough monitor will be performed at baseline and at 1mth and 3 months post treatment 2 NCT04020380 ND Not yet recruiting
Progressive fibrotic pulmonary sarcoidosis Pirfenidone 267 mg 3/d Change in FVC and Time until clinical worsening 4 NCT03260556 Placebo Recruiting
Pulmonary sarcoidosis Canakinumab (300 mg subcutaneous each month for 6 months) Change between baseline and week 24 in pulmonary function as measured by spirometry 2 NCT02888080 Placebo Completed/not available
Corticodependent pulmonary sarcoidosis Tofacitinib 5 mg twice a day 50% reduction in corticosteroid requirement in at least 60% of subjects 1 NCT03793439 ND Recruiting
Pulmonary sarcoidosis (HySSAS) Hydroxychloroquine + prednisone (Hydroxychloroquine per os 200 mg/die (or adjusted for body weight if less than 61 kg), twice/day + prednisone 0.15 mg/kg per os daily, once/day for 3 months, than for further 6 months between responders). The primary efficacy measure is the per-subject overall success rate at the 3-month visit 3 NCT02200146 Prednisone completed without results posted
Chronic pulmonary sarcoidosis (ACPS) Acthar Gel (ACTH) 80 or 40 units ACTHAR gel will be given twice a week for 22 weeks after initial loading Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire 4 NCT02188017 ND Unknown status
Chronic pulmonary sarcoidosis Acthar Gel (ACTH) 80 units twice weekly Assessment of sarcoidosis treatment score 4 NCT03320070 Placebo Recruiting
Cutaneous sarcoidosis Tofacitinib 5 mg twice a day Change in Cutaneous Sarcoidosis Activity and Morphology Instrument ND NCT03910543 ND Recruiting
Cutaneous sarcoidosis Acthar Gel (ACTH) 40 or 80 units twice weekly (phase2/phase 3) The change in SASI induration & erythema score 3 NCT02348905 ND Unknown status
Central nervous system sarcoidosis Acthar Gel (ACTH) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 48 weeks on therapy Proportion of patients with clinically significant improvement - successful glucocorticoid tapering 4 NCT02920710 ND Recruiting
Central nervous system sarcoidosis Acthar Gel (ACTH) 80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12 On MRI: change in total number of lesions and in the number and size of enhancing lesions 1, 3, 6 months and 12 months relative to baseline 4 NCT02298491 ND Completed
Sarcoidosis and uveitis (any active uveitis) Acthar Gel (ACTH) 80 U daily for 10 days, then 80 U twice weekly for up to a total of 24 weeks on therapy Proportion of patients with clinically significant improvement in visual acuity ND NCT02725177 ND Recruiting
Sarcoidosis and uveitis Acthar Gel (ACTH) 40 units twice weekly injections in patients who have sarcoid uveitis Degree of aqueous and vitreous inflammatory cells-change is being assessed by SUN score (Standardization of uveitis nomenclature) ND NCT03473964 ND Recruiting
Sarcoidosis hypercalcemia Acthar Gel (ACTH) 80 units twice a week for 12 week Reduction of 24-hour urine calcium 3 NCT02155803 ND Unknown status
Corticosteroid dependent sarcoidosis Sarilumab (200 mg subcutaneous every two weeks) flare-free survival of sarilumab-treated patients compared to placebo-treated controls 2 NCT04008069 Placebo Not yet recruiting
Severe extrathoracic sarcoidosis (induction protocol with infliximab) EFRITES trial Infliximab (Experimental: INFLIXIMAB 5 mg/kg D1-D15, then infliximab every 4 weeks W6-W10-W14/Placebo: placebo injection D1-D15 then infliximab 5 mg/kg W6-W8-W12-W16-W20) Percentage of patients [Time Frame: week 6] who have a severity assessment score (ePOST score) inferior to 1 in all organs and absence of hypercalcemia at W6, whatever the corticosteroid dosage received 3 NCT03704610 Placebo Not yet recruiting
Efficacy of remission-induction regimen (cyclophosphamide versus
infliximab) for severe extrathoracic sarcoidosis
Infliximab 5 mg/kg D1-D15 and every 6 weeks, in
association with low dose methotrexate (10 mg/week)
Corticosteroids tapering regimen until 0.1 mg/kg/day
evaluate the efficacy of infliximab and cyclophosphamide to induce remission in sarcoidosis with extrathoracic localization and serious organ involvement or relapse with at least one first-line immunosuppressive drug ND Eudra CT
2015-002442-31
IV CYC Recruiting

Abbreviations: ACTH, adrenocorticotrophin hormone; D, day; ePOST, extrapulmonary physician organ severity tool; FDG PET scan, fluoro-deoxy-glucose positron emission tomography; FVC, forced vital capacity; IV CYC, intravenous cyclophosphamide; MRI, magnetic resonance imaging; ND, no data; W, week.