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Idiopathic Pulmonary FibrosisPhase 2NCT05722964

Study on Intravenous Injection of SHR-1906 in the Treatment of Idiopathic Pulmonary Fibrosis

A Phase 2 study testing SHR-1906 in people with Idiopathic Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy and safety of intravenous SHR-1906 in the treatment of idiopathic pulmonary fibrosis. The study is divided into four stages: screening period, baseline period, treatment period and safe follow-up period. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
SHR-1906
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
29 Mar 2023to 7 Aug 2024
Phase
Phase 2
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 40 to 80, inclusive, at the time of screening；
  • IPF diagnosed according to ATS/ERS/JRS/ALAT guidelines (2022) (HRCT diagnosis UIP type/possible UIP type (standard HRCT confirmed by central review in recent 3 months) with or without pathological UIP type/possible UIP type (pathology refers to frozen lung biopsy or surgical/thoracoscopic lung biopsy)；
  • 90% ≥ FVCpp ≥ 45% during screening period and the first day;
  • The percent of predicted DLCO value (corrected by Hb value) at screening is ≥ 30% and ≤ 90%;
  • Before the screening period, pirfenidone or nidanib with stable dose ≥ 8 weeks (pirfenidone ≥ 1200 mg/denidanib ≥ 200 mg/d) can continue to maintain treatment with stable dose during the study period; Or at least 4 weeks before the screening period, pirfenidone or nidanib was not used (pirfenidone or nidanib was refused due to intolerance or various factors) ；

Who cannot join

  • Evidence of any of the following significant obstructive pulmonary disease: (1) The ratio of forced expiratory volume/forced vital capacity (FEV1/FVC) at the first second is < 0.70 (after using bronchodilator) or (2) HRCT shows that emphysema is greater than fibrosis;
  • Interstitial lung diseases (ILD) other than IPF include but are not limited to: any other type of idiopathic interstitial pneumonia; Lung diseases related to contact with fibroblasts or other environmental toxins or drugs; Other types of occupational lung diseases; Granulomatous lung disease; Pulmonary vascular disease; Systemic diseases include vasculitis infectious diseases (i.e. Tuberculosis) and connective tissue diseases If the diagnosis is unclear, serological examination and/or multidisciplinary expert group review should be conducted to confirm IPF or other types of ILD diagnosis;
  • A history of other types of respiratory diseases, including respiratory tract, lung parenchyma, pleural cavity, mediastinum, diaphragm or chest wall diseases or disorders, such as acute respiratory infection, active tuberculosis, etc., which researchers believe will affect the primary endpoint of the study or otherwise affect the participation of subjects in the study;

Trial locations and contacts

1 site in 1 country.

China1 site

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: Efficacy and Safety of Intravenous Infusion of SHR-1906 in Patients With Idiopathic Pulmonary Fibrosis: a Multicenter, Randomized, Double-blind, Parallel Placebo-controlled Phase II Trial

To evaluate the efficacy and safety of intravenous SHR-1906 in the treatment of idiopathic pulmonary fibrosis. The study is divided into four stages: screening period, baseline period, treatment period and safe follow-up period. It is planned that 108 patients will be randomly assigned to the following three treatment groups for treatment

Being tested
SHR-1906, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1906Drug

    Intravenous injection

  • SHR-1906Drug

    Intravenous injection

  • PlaceboDrug

    Placebo，Intravenous injection

Study groups in NCT05722964
Study groupRoleWhat they receive
SHR-1906，-Dose AExperimentalNot described
Receives: Drug: SHR-1906
SHR-1906，- Dose BExperimentalNot described
Receives: Drug: SHR-1906
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24

    Measured: Baseline, Week 24

Secondary outcomes (9)

  1. Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24

    Measured: Baseline, Week 4, 8, 12, 16, 20, 24

  2. Change from Baseline in FVC% (Percent of Predicted FVC value) to Week 4, 8, 12, 16, 20

    Measured: Baseline, Week 4, 8, 12, 16, 20

  3. Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) to Week 12 and Week 24

    Measured: Baseline, Week 12 and Week 24

  4. Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Scores to Week 12 and Week 24

    Measured: Baseline, Week 12 and Week 24]

  5. Number of Praticipants with an Acute Exacerbation of IPF

    Measured: Start of Treatment to end of study (approximately 28 weeks)

  6. All-cause mortality

    Measured: Start of Treatment to end of study (approximately 28 weeks)

  7. Adverse events

    Measured: Start of Treatment to end of study (approximately 28 weeks)

  8. Serum concentration of SHR-1906

    Measured: Start of Treatment to end of study (approximately 28 weeks)

  9. Proportion of anti-SHR-1906 antibody (ADA) formed during the study from baseline

    Measured: Start of Treatment to end of study (approximately 28 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start29 Mar 2023
  3. Primary completion7 Aug 2024
  4. Study completion7 Aug 2024

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparison of SHR-1906 injection and placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05722964
Sponsor's protocol ID
SHR-1906-201
Status last verified
Mar 2025
First submitted
11 Jan 2023
Last updated
24 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1906 in people with Idiopathic Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical Co., Ltd 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 3 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: finished, as of the sponsor's last update on 24 Mar 2025. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05722964.

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 24 Mar 2025.

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