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
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