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New treatment option for Sarcoidosis, Pulmonary
Official title RCT of Nintedanib in Fibrotic Sarcoidosis
ClinicalTrials.gov ID: NCT06479603
What this study is testing
What is Nintedanib?
Nintedanib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sarcoidosis, pulmonary.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sarcoidosis is generally managed with outdoor immune modulatory drugs, most commonly oral steroids and at times drugs like methotrexate or azathioprine as a steroid sparing agent. Around 15-20% of sarcoidosis patient develop fibrosis of the lung parenchyma.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Age more than 18 years
- Diagnosed with pulmonary sarcoidosis (clinico-radiologic presentation consistent with pulmonary sarcoidosis (with or without extrapulmonary...
- Presence of signs of fibrosis on a computed tomography scan such as coarse reticulation, irregular lines, traction bronchiectasis, fibrotic masses...
- Having symptoms of breathlessness grade 1 or more on the modified Medical Research Council (mMRC) scale or persistent cough for more than 3 months
- Forced vital capacity (FVC) \<80% predicted value for the age and sex of the subject using the reference equations for our people OR an exertional...
You likely can't join if
- Known cardiopulmonary or other comorbid illness that can explain the subject's illness except group 3 pulmonary hypertension due to fibrotic...
- Hypersensitivity or contraindication to nintedanib (including high dose antiplatelets or anticoagulants, and bleeding diatheses)
- Received an antifibrotic drug such as pirfenidone or nintedanib for ≥8 weeks in the past one year
- Baseline deranged liver function (alanine aminotransferase and aspartate aminotransferase or bilirubin more than 1 5 times the upper normal limit...
- Serum creatinine higher than 2.0 mg/dL
- Uncontrolled congestive heart failure
See the full eligibility criteria
- Age more than 18 years
- Diagnosed with pulmonary sarcoidosis (clinico-radiologic presentation consistent with pulmonary sarcoidosis (with or without extrapulmonary involvement) along with presence of non-necrotising granulomatous inflammation...
- Presence of signs of fibrosis on a computed tomography scan such as coarse reticulation, irregular lines, traction bronchiectasis, fibrotic masses, or honeycombing involving ≥20% of the lung fields on visual examination
- Having symptoms of breathlessness grade 1 or more on the modified Medical Research Council (mMRC) scale or persistent cough for more than 3 months
- Forced vital capacity (FVC) \<80% predicted value for the age and sex of the subject using the reference equations for our people OR an exertional desaturation of 4% or more on a six-minute walk test (6MWT)
- Receiving stable immunomodulatory treatment which includes standard of care drugs such as glucocorticoids alone or in combination with methotrexate, azathioprine, or mycophenolate mofetil for more than 3 months in a...
- Known cardiopulmonary or other comorbid illness that can explain the subject's illness except group 3 pulmonary hypertension due to fibrotic pulmonary sarcoidosis
- Hypersensitivity or contraindication to nintedanib (including high dose antiplatelets or anticoagulants, and bleeding diatheses)
- Received an antifibrotic drug such as pirfenidone or nintedanib for ≥8 weeks in the past one year
- Baseline deranged liver function (alanine aminotransferase and aspartate aminotransferase or bilirubin more than 1 5 times the upper normal limit [except in the case of Gilbert's syndrome])
- Serum creatinine higher than 2.0 mg/dL
- Uncontrolled congestive heart failure
- Other serious concomitant medical illness (eg, cancer), chronic debilitating illness (other than chronic HP), or drug abuse
- Pregnancy (documented by urine pregnancy test) or breastfeeding
- Unwilling to participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.