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Not yet recruitingNCT07668895Updated Oct 15, 2026

Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis

A Phase 2/3 interventional study of Prednisone and Compound betamethasone in Sarcoidosis, Pulmonary, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Peking Union Medical College Hospital · Phase 2/3, Interventional, and Treatment

Updated Oct 15, 2026Start date movedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

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
02

Conditions studied

  • Sarcoidosis, Pulmonary

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03

In context

Sarcoidosis, Pulmonary

67 studies on the registry are indexed under Sarcoidosis, Pulmonary; 16 are open to participants now.

This study's planned enrollment of 126 is above the median of 55 across 50 interventional studies indexed under Sarcoidosis, Pulmonary.

Browse Sarcoidosis, Pulmonary studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (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 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 .

Exclusion criteria

Exclusion Criteria:

  • Patient or family members are unable to understand the conditions and objectives of this study, or are unable to provide .
  • 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 during the study period and within 3 months after the study ends.
  • Active requiring treatment (surgery, medical therapy, or radiotherapy).
  • to Diprospan (Compound Betamethasone) or prednisone.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • Active comparator
    Oral Prednisone Group

    Drug: Prednisone

  • Experimental
    Intramuscular Compound Betamethasone Group

    Drug: Compound betamethasone

Interventions

  • 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.

  • DrugCompound betamethasone

    Drug pages: Betamethasone sodium phosphate · Betamethasone dipropionate

    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.

06

What researchers measure

Primary outcomes

  1. Change from baseline in percent predicted FVC after 24 weeks of treatment (%)

    Time frame: 24 weeks

Secondary outcomes

  1. Change in lymph node score as assessed by chest CT

    Time frame: 24 weeks, 36 weeks and 48 weeks

  2. Change from baseline in absolute FVC at 24 weeks of treatment (mL)

    Time frame: 24 weeks

  3. Change from baseline in percent predicted DLCO at 24 weeks of treatment (%)

    Time frame: 24 weeks

  4. Change from baseline in percent predicted FEV1 at 24 weeks of treatment (%)

    Time frame: 24 weeks

  5. Relapse rate of sarcoidosis at 24 weeks after treatment initiation

    Time frame: 24 weeks

  6. Relapse rate of sarcoidosis at 36 and 48 weeks after treatment initiation

    Time frame: 36 weeks and 48 weeks

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Start date
Jul 2026→Nov 2026
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Start date Jul 2026→Nov 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07668895
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Oct 15, 2026

Study contacts

Hui Huang
Contact
pumchhh@126.com
86+13391587917

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Betamethasone sodium phosphate · Betamethasone dipropionate

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