Sarcoidosis, PulmonaryPhase 4NINSARCNCT06479603
RCT of Nintedanib in Fibrotic Sarcoidosis
A Phase 4 study testing Nintedanib in people with Sarcoidosis, Pulmonary, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Nintedanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jun 2024to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 in any of the involved organ/tissue and exclusion of a known cause for the granulomatous inflammation OR in the absence of demonstration of granulomatous inflammation in tissues, a diagnosis of fibrotic pulmonary sarcoidosis on a multidisciplinary discussion (enrolment of subjects meeting the latter criteria will be capped at 20% of the planned sample size)
- 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 subjects 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 stable dose
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh
Sahajal Dhooria, MD, DM, +917087002015, sahajal@gmail.com
About this study
Official title: A Randomised Controlled Trial to Study the Efficacy and Safety of Nintedanib in Fibrotic Sarcoidosis
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. The effect of antifibrotics in such patients needs more studies. Nintedanib has been used with good results in patients with fibrosing interstitial lung disease like IPF, SSC- ILD, and other progressive fibrosing ILD. By using nintedanib in fibrotic sarcoidosis it may be possible to limit the functional disability in these patients by slowing the rate of fibrosis and loss of lung function. The use of nintedanib if results in decrease in fibrosis and consequent decline in loss of lung function then it may be a safe and viable option for such patients.
The hypothesis of this study is that in patients with fibrotic sarcoidosis on standard of care anti-inflammatory therapy, nintedanib may help in reducing the rate of decline in lung function and progressive fibrosis. The aim is to evaluate the efficacy and safety of nintedanib in subjects with fibrotic sarcoidosis
Read the detailed description
Setting: This prospective randomised controlled trial will be conducted in the Chest Clinic of the Department of Pulmonary Medicine, PGIMER, Chandigarh after approval from the ethics committee.
Study design: Open label parallel group randomized controlled trial Blinding: This will be an open label trial. Neither the subject nor the investigators will be blinded to the assigned group. The individual administering the Kings Sarcoid Questionnaire (KSQ) will be blinded to the group allocation.
Study participants: Diagnosed cases of pulmonary sarcoidosis of fibrotic phenotype who are on stable immunosuppressive therapy would be enrolled after screening for inclusion and exclusion criteria. Consecutive subjects with fibrotic sarcoidosis will be screened for this study. The subjects will undergo the following investigations: complete blood counts, liver and kidney function tests, and an electrocardiogram (ECG) in addition to a thin-section chest CT (if a recent scan within 6 months of screening is unavailable) or a positron emission tomography (PET) if indicated clinically, spirometry, and a six-minute walk test (6MWT). A venous blood sample (total of 10 mL) will be collected in plain and EDTA vials and stored for cytokine analysis and other testing.
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Nintedanib, Standard of care
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
The subjects will receive oral nintedanib. It will be prescribed to be taken after meals with 12 hrs gap between doses. The drug will be started at a dose of 100 mg twice daily. After 2 weeks, the dose will be titrated up to 150 mg twice daily, which will be continued till the end of 52 weeks. The standard-of-care immunosuppressive treatment will be continued along with the study drug (nintedanib). In case of intolerance to the 300 mg/day dose of nintedanib, the dose will be reduced to 100 mg twice daily. In case of severe adverse effects, the drug will be stopped and reintroduced after a period of up to 1-4 weeks. A dose of 100 mg twice daily will be started and continued. One attempt to titrate the dose up to 150 mg twice daily will be permitted.
Standard of careDrug
The subjects will receive the standard-of-care immunosuppressive treatment alone that may include glucocorticoids and other steroid-sparing agents that the subject would already be receiving.
| Study group | Role | What they receive |
|---|---|---|
| NIntedanib | Active comparator | The subjects will receive oral nintedanib. It will be prescribed to be taken after meals with 12 hrs gap between doses. The drug will be started at a dose of 100 mg twice daily. After 2 weeks, the dose will be titrated up to 150 mg twice daily, which will be continued till the end of 52 weeks. The standard-of-care immunosuppressive treatment will be continued along with the study drug (nintedanib). In case of intolerance to the 300 mg/day dose of nintedanib, the dose will be reduced to 100 mg twice daily. Receives: Drug: Nintedanib |
| Standard of care | Active comparator | The subjects will receive the standard-of-care immunosuppressive treatment alone. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the mean change in forced vital capacity (FVC) between the study groups
The FVC will be measured at baseline and 12 months using spirometry performed by an expert technician
Measured: 12 months
Secondary outcomes (5)
The difference in the mean change in forced expiratory volume in one sec (FEV1) between the study groups
The FEV1 will be measured at baseline and 12 months using spirometry performed by an expert technician
Measured: 12 months
The difference in the mean change in the 6-minute walk distance (6MWD) between the study groups at the end of 12 months
The 6MWD will be measured at baseline and 12 months using a 6MWT performed by an expert technician
Measured: 12 months
The difference in the mean change in the diffusing capacity of lung for carbon mono oxide (DLCO) between the study groups
The DLCO will be measured at baseline and 12 months and performed by an expert technician
Measured: 12 months
Treatment-related adverse effects
Number of treatment-related adverse effects in each arm. The grading of adverse events according to the Common Terminology Criteria for Adverse Events version 5.0. These will include diarrhea, gastrointestinal disturbances, liver function test abnormalities, nausea, vomiting, and any other adverse effects reported by the study subject.
Measured: 12 months
Change in the sarcoidosis-related quality-of-life
Change in the sarcoidosis-related quality-of-life will be assessed by the score on the King's Sarcoidosis Questionnaire. This is a 29-item questionnaire with questions in 5 domains. The score ranges from 0 to 100 with higher scores representing better sarcoidosis-related health status
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start30 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahajal Dhooria, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479603
- Sponsor's protocol ID
- INT/IEC/2023/SPL-1214
- Acronym
- NINSARC
- Status last verified
- Oct 2024
- First submitted
- 24 Jun 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data of the outcomes presented in the primary publication arising out of this study will be shared with interested investigators on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Study the Efficacy and Safety of Nintedanib in Fibrotic Sarcoidosis
- ClinicalTrials.gov ID
- NCT06479603
- Acronym / sponsor ID
- NINSARC / INT/IEC/2023/SPL-1214
- Conditions
- Sarcoidosis, Pulmonary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The effect of antifibrotics in such patients needs more studies. Nintedanib has been used with good results in patients with fibrosing interstitial lung disease like IPF, SSC- ILD, and other progressive fibrosing ILD. By using nintedanib in fibrotic sarcoidosis it may be possible to limit the functional disability in these patients by slowing the rate of fibrosis and loss of lung function. The use of nintedanib if results in decrease in fibrosis and consequent decline in loss of lung function then it may be a safe and viable option for such patients.
The hypothesis of this study is that in patients with fibrotic sarcoidosis on standard of care anti-inflammatory therapy, nintedanib may help in reducing the rate of decline in lung function and progressive fibrosis. The aim is to evaluate the efficacy and safety of nintedanib in subjects with fibrotic sarcoidosis
Detailed description
Setting: This prospective randomised controlled trial will be conducted in the Chest Clinic of the Department of Pulmonary Medicine, PGIMER, Chandigarh after approval from the ethics committee.
Study design: Open label parallel group randomized controlled trial Blinding: This will be an open label trial. Neither the subject nor the investigators will be blinded to the assigned group. The individual administering the Kings Sarcoid Questionnaire (KSQ) will be blinded to the group allocation.
Study participants: Diagnosed cases of pulmonary sarcoidosis of fibrotic phenotype who are on stable immunosuppressive therapy would be enrolled after screening for inclusion and exclusion criteria. Consecutive subjects with fibrotic sarcoidosis will be screened for this study. The subjects will undergo the following investigations: complete blood counts, liver and kidney function tests, and an electrocardiogram (ECG) in addition to a thin-section chest CT (if a recent scan within 6 months of screening is unavailable) or a positron emission tomography (PET) if indicated clinically, spirometry, and a six-minute walk test (6MWT). A venous blood sample (total of 10 mL) will be collected in plain and EDTA vials and stored for cytokine analysis and other testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIntedanib | Active comparator | Drug: NintedanibThe subjects will receive oral nintedanib. It will be prescribed to be taken after meals with 12 hrs gap between doses. The drug will be started at a dose of 100 mg twice daily. After 2 weeks, the dose will be titrated up to 150 mg twice daily, which will be continued till the end of 52 weeks. The standard-of-care immunosuppressive treatment will be continued along with the study drug (nintedanib). In case of intolerance to the 300 mg/day dose of nintedanib, the dose will be reduced to 100 mg twice daily. |
| Standard of care | Active comparator | Drug: Standard of careThe subjects will receive the standard-of-care immunosuppressive treatment alone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 in any of the involved organ/tissue and exclusion of a known cause for the granulomatous inflammation OR in the absence of demonstration of granulomatous inflammation in tissues, a diagnosis of fibrotic pulmonary sarcoidosis on a multidisciplinary discussion (enrolment of subjects meeting the latter criteria will be capped at 20% of the planned sample size)
- 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 subjects OR an exertional desaturation of 4% or more on a six-minute walk test (6MWT)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibThe subjects will receive oral nintedanib. It will be prescribed to be taken after meals with 12 hrs gap between doses. The drug will be started at a dose of 100 mg twice daily. After 2 weeks, the dose will be titrated up to 150 mg twice daily, which will be continued till the end of 52 weeks. The standard-of-care immunosuppressive treatment will be continued along with the study drug (nintedanib). In case of intolerance to the 300 mg/day dose of nintedanib, the dose will be reduced to 100 mg twice daily. In case of severe adverse effects, the drug will be stopped and reintroduced after a period of up to 1-4 weeks. A dose of 100 mg twice daily will be started and continued. One attempt to titrate the dose up to 150 mg twice daily will be permitted. | Drug | NIntedanib |
| Standard of careThe subjects will receive the standard-of-care immunosuppressive treatment alone that may include glucocorticoids and other steroid-sparing agents that the subject would already be receiving. | Drug | Standard of care |
Primary outcome
The difference in the mean change in forced vital capacity (FVC) between the study groups
Time frame: 12 months
The FVC will be measured at baseline and 12 months using spirometry performed by an expert technician
5 secondary outcomes
The difference in the mean change in forced expiratory volume in one sec (FEV1) between the study groups
Time frame: 12 months
The difference in the mean change in the 6-minute walk distance (6MWD) between the study groups at the end of 12 months
Time frame: 12 months
The difference in the mean change in the diffusing capacity of lung for carbon mono oxide (DLCO) between the study groups
Time frame: 12 months
Treatment-related adverse effects
Time frame: 12 months
Change in the sarcoidosis-related quality-of-life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Yes. De-identified data of the outcomes presented in the primary publication arising out of this study will be shared with interested investigators on a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Postgraduate Institute of Medical Education and Research
Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nintedanib in people with Sarcoidosis, Pulmonary, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the mean change in forced vital capacity (FVC) between the study groups (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.