Table 4.
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.