Sarcoidosis, PulmonaryPhase 2/3NCT07668895
Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
A Phase 2/3 study testing Prednisone and Compound betamethasone in people with Sarcoidosis, Pulmonary, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether a study drug called Compound Betamethasone (also known as Diprospan) works to treat pulmonary sarcoidosis in people with early-stage disease (stage I or II). It will also learn about its safety compared to the standard treatment, prednisone. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Prednisone and Compound betamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Jul 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosed within the past 3 months with stage I-II (based on chest CT) treatment-naive pulmonary sarcoidosis, meeting the following: A. Histopathological diagnosis of sarcoidosis via tissue biopsy (bronchial mucosa, intrathoracic lymph nodes, lung, pleura, etc.) obtained during bronchoscopy; B. Chest HRCT showing mediastinal and hilar lymphadenopathy, with or without pulmonary infiltrates (nodules, patchy opacities, ground-glass opacities, etc.); C. CT stage confirmed independently by at least two experts in the field (among three experts reviewing the chest HRCT images).
- Requiring systemic glucocorticoid therapy.
- Able to complete scheduled follow-up visits.
- Patient and family members understand the study protocol, are willing to participate in this study, and are able to provide written informed consent.
Who cannot join
- Patient or family members are unable to understand the conditions and objectives of this study, or are unable to provide informed consent.
- Subjects who cannot comply with the follow-up schedule as required by the protocol.
- Presence of other serious diseases that, in the investigator's judgment, may affect patient safety or compliance.
- Any significant clinical or laboratory abnormalities that, in the investigator's judgment, may affect safety evaluation.
- Pregnant or breastfeeding women, or patients who cannot use effective contraception during the study period and within 3 months after the study ends.
- Active malignancy requiring treatment (surgery, medical therapy, or radiotherapy).
- Hypersensitivity to Diprospan (Compound Betamethasone) or prednisone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100730
Hui Huang, 86+13391587917, pumchhh@126.com
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
The goal of this clinical trial is to learn whether a study drug called Compound Betamethasone (also known as Diprospan) works to treat pulmonary sarcoidosis in people with early-stage disease (stage I or II). It will also learn about its safety compared to the standard treatment, prednisone.
The main questions it aims to answer are:
Read more
- How much does the study drug improve lung function (measured by a test called FVC%) after 24 weeks of treatment?
- How does it compare to prednisone in controlling symptoms, reducing chest lymph node swelling, and preventing relapse? Researchers will compare Compound Betamethasone injections (given once every 4 weeks) to prednisone pills (taken daily with a gradual dose reduction).
Participants will:
- Receive either the study drug injection or prednisone pills for 24 weeks
- Visit the clinic for checkups and lung function tests at weeks 6, 12, and 24
- Have chest CT scans and blood tests to monitor their condition and any side effects
- Be followed up for additional 24 weeks (up to week 48) to see if the disease comes back after treatment stops
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Prednisone, Compound betamethasone
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Prednisone, oral administration. Starting dose of 40 mg once daily for 2 weeks, followed by gradual tapering according to the following schedule: reduce by half a tablet (2.5 mg) each week. When the dose is reduced to 1 tablet (5 mg) once daily, maintain for 2 weeks; then reduce to half a tablet (2.5 mg) once daily for 2 weeks; then reduce to half a tablet (2.5 mg) every other day for 2 weeks; then reduce to half a tablet (2.5 mg) twice weekly for 2 weeks, then discontinue. Total treatment duration is 24 weeks.
Compound betamethasoneDrug
Compound Betamethasone injection, administered intramuscularly. Each injection is 1 mL, given once every 4 weeks for a total of 6 injections, with a treatment period of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oral Prednisone Group | Active comparator | Not described Receives: Drug: Prednisone |
| Intramuscular Compound Betamethasone Group | Experimental | Not described Receives: Drug: Compound betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in percent predicted FVC after 24 weeks of treatment (%)
Measured: 24 weeks
Secondary outcomes (6)
Change in lymph node score as assessed by chest CT
Measured: 24 weeks, 36 weeks and 48 weeks
Change from baseline in absolute FVC at 24 weeks of treatment (mL)
Measured: 24 weeks
Change from baseline in percent predicted DLCO at 24 weeks of treatment (%)
Measured: 24 weeks
Change from baseline in percent predicted FEV1 at 24 weeks of treatment (%)
Measured: 24 weeks
Relapse rate of sarcoidosis at 24 weeks after treatment initiation
Measured: 24 weeks
Relapse rate of sarcoidosis at 36 and 48 weeks after treatment initiation
Measured: 36 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (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.
- More trials run by Peking Union Medical College 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
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668895
- Sponsor's protocol ID
- K10933
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
- ClinicalTrials.gov ID
- NCT07668895
- Acronym / sponsor ID
- K10933
- Conditions
- Sarcoidosis, Pulmonary
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Jun 2026 (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.
The goal of this clinical trial is to learn whether a study drug called Compound Betamethasone (also known as Diprospan) works to treat pulmonary sarcoidosis in people with early-stage disease (stage I or II). It will also learn about its safety compared to the standard treatment, prednisone.
The main questions it aims to answer are:
- How much does the study drug improve lung function (measured by a test called FVC%) after 24 weeks of treatment?
- How does it compare to prednisone in controlling symptoms, reducing chest lymph node swelling, and preventing relapse? Researchers will compare Compound Betamethasone injections (given once every 4 weeks) to prednisone pills (taken daily with a gradual dose reduction).
Participants will:
- Receive either the study drug injection or prednisone pills for 24 weeks
- Visit the clinic for checkups and lung function tests at weeks 6, 12, and 24
- Have chest CT scans and blood tests to monitor their condition and any side effects
- Be followed up for additional 24 weeks (up to week 48) to see if the disease comes back after treatment stops
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Prednisone Group | Active comparator | Drug: Prednisone |
| Intramuscular Compound Betamethasone Group | Experimental | Drug: Compound betamethasone |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Diagnosed within the past 3 months with stage I-II (based on chest CT) treatment-naive pulmonary sarcoidosis, meeting the following: A. Histopathological diagnosis of sarcoidosis via tissue biopsy (bronchial mucosa, intrathoracic lymph nodes, lung, pleura, etc.) obtained during bronchoscopy; B. Chest HRCT showing mediastinal and hilar lymphadenopathy, with or without pulmonary infiltrates (nodules, patchy opacities, ground-glass opacities, etc.); C. CT stage confirmed independently by at least two experts in the field (among three experts reviewing the chest HRCT images).
- Requiring systemic glucocorticoid therapy.
- Able to complete scheduled follow-up visits.
- Patient and family members understand the study protocol, are willing to participate in this study, and are able to provide written informed consent.
Key exclusion criteria (7 listed)
- Patient or family members are unable to understand the conditions and objectives of this study, or are unable to provide informed consent.
- Subjects who cannot comply with the follow-up schedule as required by the protocol.
- Presence of other serious diseases that, in the investigator's judgment, may affect patient safety or compliance.
- Any significant clinical or laboratory abnormalities that, in the investigator's judgment, may affect safety evaluation.
- Pregnant or breastfeeding women, or patients who cannot use effective contraception during the study period and within 3 months after the study ends.
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 |
|---|---|---|
| PrednisonePrednisone, oral administration. Starting dose of 40 mg once daily for 2 weeks, followed by gradual tapering according to the following schedule: reduce by half a tablet (2.5 mg) each week. When the dose is reduced to 1 tablet (5 mg) once daily, maintain for 2 weeks; then reduce to half a tablet (2.5 mg) once daily for 2 weeks; then reduce to half a tablet (2.5 mg) every other day for 2 weeks; then reduce to half a tablet (2.5 mg) twice weekly for 2 weeks, then discontinue. Total treatment duration is 24 weeks. | Drug | Oral Prednisone Group |
| Compound betamethasoneCompound Betamethasone injection, administered intramuscularly. Each injection is 1 mL, given once every 4 weeks for a total of 6 injections, with a treatment period of 24 weeks. | Drug | Intramuscular Compound Betamethasone Group |
Primary outcome
Change from baseline in percent predicted FVC after 24 weeks of treatment (%)
Time frame: 24 weeks
6 secondary outcomes
Change in lymph node score as assessed by chest CT
Time frame: 24 weeks, 36 weeks and 48 weeks
Change from baseline in absolute FVC at 24 weeks of treatment (mL)
Time frame: 24 weeks
Change from baseline in percent predicted DLCO at 24 weeks of treatment (%)
Time frame: 24 weeks
Change from baseline in percent predicted FEV1 at 24 weeks of treatment (%)
Time frame: 24 weeks
Relapse rate of sarcoidosis at 24 weeks after treatment initiation
Time frame: 24 weeks
Relapse rate of sarcoidosis at 36 and 48 weeks after treatment initiation
Time frame: 36 weeks and 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
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 Prednisone and Compound betamethasone in people with Sarcoidosis, Pulmonary, run by Peking Union Medical College 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Huang (86+13391587917, pumchhh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in percent predicted FVC after 24 weeks of treatment (%) (time frame: 24 weeks). 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 15 Oct 2026.