Systemic SclerosisPhase 2/3NCT03068234
Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis
A Phase 2/3 study testing Pirfenidone and Steroids in people with Systemic Sclerosis, run by RenJi Hospital at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Pirfenidone and Steroids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- May 2017to Dec 2019
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill EULAR/ACR classification criteria (2013) for systemic sclerosis (SSc).
- Subjects must have mRSS≥10 at screening stage
- Subjects must have signs of fibrosis in their chest CT at screening stage
- If a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (ΔmRSS≤-2)
Who cannot join
- Subjects with other connective tissue diseases overlapping with SSc
- Subjects with skin atrophy as the main cutaneous manifestation
- Subjects with active digital ulcers or gangrene
- Active severe SSc-driven renal disease or heart dysfunction at screening
- Subjects with significant hematologic abnormalities
- Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
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- Clinically significant active infection including ongoing and chronic infections
- History of human immunodeficiency virus (HIV)
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C
- Active tuberculosis
- Live or attenuated vaccine within 4 weeks prior to screening
- Subjects with significant hematologic abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic Sclerosis
This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis.
Read the detailed description
All patients enrolled should suffer from moderate to severe skin fibrosis at the screening stage.
The study period is 52 week. The study contains two stages, a 24-week blind stage following with open stage for another 24-week period of time. Subjects will receive pirfenidone or placebo randomized in the first 24-week and will all receive pirfenidone treatment in the second 24-week, with of combination of low dose steroids.
The secondary outcomes of this study include but not limit to safety, improvement of lung fibrosis and digital ulcer burden.
- Conditions
- Systemic Sclerosis
- Being tested
- Pirfenidone, Placebo oral capsule, Steroids
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.
Placebo oral capsuleDrug
Placebo for pirfenidone capsule
SteroidsDrug
Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone group | Experimental | The subjects will receive pirfenidone from 200mg three times a day, oral administrated, with low dose steroids. Receives: Drug: Pirfenidone; Drug: Steroids |
| Control group | Placebo comparator | The subjects will receive placebo within first 24-week, and pirfenidone 200mg three times a day for the second 24-week, with low dose steroids. Receives: Drug: Pirfenidone; Drug: Placebo oral capsule; Drug: Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rodnan Skin Score (mRSS）
A semi-quantitative score for skin fibrosis of every subjects
Measured: Week 52
Secondary outcomes (17)
Modified Rodnan Skin Score
A semi-quantitative score for skin fibrosis of every subjects
Measured: Week 24
Assessment of chest CT
Semi-quantitative scale for fibrotic changes in chest CT images from an individual patient
Measured: Week 52
Assessment of chest CT
Semi-quantitative scale for fibrotic changes in chest CT images from an individual patient
Measured: Week 24
Forced vital capacity
A marker for lung function that may decrease with pulmonary fibrosis
Measured: Week 52
Forced vital capacity
A marker for lung function that may decrease with pulmonary fibrosis
Measured: Week 24
Diffusing capacity
Another marker for lung function that may decrease with pulmonary fibrosis
Measured: Week 52
Diffusing capacity
Another marker for lung function that may decrease with pulmonary fibrosis
Measured: Week 24
6 minute walk test
A simple, well-accepted and quantitative clinical exam to test heart and lung function
Measured: Week 52
6 minute walk test
A simple, well-accepted and quantitative clinical exam to test heart and lung function
Measured: Week 24
Hand function assessment
Hand function will be measured by Cochin Hand Function Scale
Measured: Week 52
Hand function assessment
Hand function will be measured by Cochin Hand Function Scale
Measured: Week 24
Proportion of subjects with increased mRSS
Proportion of subjects with ∆mRSS≥5
Measured: Week 52
Proportion of subjects with increased mRSS
Proportion of subjects with ∆mRSS≥5
Measured: Week 24
Quality of life
Assessed by the health assessment questionnaire disability index
Measured: Week 52
Quality of life
Assessed by the health assessment questionnaire disability index
Measured: Week 24
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Week 52
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startMay 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068234
- Sponsor's protocol ID
- [2017]17
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 1 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03068234
- Acronym / sponsor ID
- [2017]17
- Conditions
- Systemic Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Mar 2017 (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.
This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis.
Detailed description
All patients enrolled should suffer from moderate to severe skin fibrosis at the screening stage.
The study period is 52 week. The study contains two stages, a 24-week blind stage following with open stage for another 24-week period of time. Subjects will receive pirfenidone or placebo randomized in the first 24-week and will all receive pirfenidone treatment in the second 24-week, with of combination of low dose steroids.
The secondary outcomes of this study include but not limit to safety, improvement of lung fibrosis and digital ulcer burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone group | Experimental | Drug: Pirfenidone, Drug: SteroidsThe subjects will receive pirfenidone from 200mg three times a day, oral administrated, with low dose steroids. |
| Control group | Placebo comparator | Drug: Pirfenidone, Drug: Placebo oral capsule, Drug: SteroidsThe subjects will receive placebo within first 24-week, and pirfenidone 200mg three times a day for the second 24-week, with low dose steroids. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fulfill EULAR/ACR classification criteria (2013) for systemic sclerosis (SSc).
- Subjects must have mRSS≥10 at screening stage
- Subjects must have signs of fibrosis in their chest CT at screening stage
- If a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (ΔmRSS≤-2)
Key exclusion criteria (12 listed)
- Subjects with other connective tissue diseases overlapping with SSc
- Subjects with skin atrophy as the main cutaneous manifestation
- Subjects with active digital ulcers or gangrene
- Active severe SSc-driven renal disease or heart dysfunction at screening
- Subjects with significant hematologic abnormalities
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 |
|---|---|---|
| PirfenidoneA chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis. | Drug | Control group, Pirfenidone group |
| Placebo oral capsulePlacebo for pirfenidone capsule | Drug | Control group |
| SteroidsLow dose of glucocorticoids, a basic treatment for patients with systemic sclerosis | Drug | Control group, Pirfenidone group |
Primary outcome
Modified Rodnan Skin Score (mRSS）
Time frame: Week 52
A semi-quantitative score for skin fibrosis of every subjects
17 secondary outcomes
Modified Rodnan Skin Score
Time frame: Week 24
Assessment of chest CT
Time frame: Week 52
Assessment of chest CT
Time frame: Week 24
Forced vital capacity
Time frame: Week 52
Forced vital capacity
Time frame: Week 24
Diffusing capacity
Time frame: Week 52
Diffusing capacity
Time frame: Week 24
6 minute walk test
Time frame: Week 52
6 minute walk test
Time frame: Week 24
Hand function assessment
Time frame: Week 52
Hand function assessment
Time frame: Week 24
Proportion of subjects with increased mRSS
Time frame: Week 52
Proportion of subjects with increased mRSS
Time frame: Week 24
Quality of life
Time frame: Week 52
Quality of life
Time frame: Week 24
Safety and Tolerability
Time frame: Week 52
Safety and Tolerability
Time frame: Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pirfenidone and Steroids in people with Systemic Sclerosis, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 12 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 1 Mar 2017. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rodnan Skin Score (mRSS） (time frame: Week 52). 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 1 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.