Rapid Progressive Interstitial Lung DiseasesPhase 2NCT05181397
The Efficacy and Safety of Tocilizumab for Severe RP-ILD Secondary to Systemic Diseases
A Phase 2 study testing Tocilizumab in people with Rapid Progressive Interstitial Lung Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
There is no confirmed drug therapy for RP-ILD. Prognosis is poor of regular treatment. The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Progressive Interstitial Lung Diseases
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2021to 1 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RP-ILD, previous or concurrent diagnosis of systemic diseases
Who cannot join
- pregnancy; uncontrolled pulmonary infections; severe cardiovascular, hepatic and renal dysfunction; unstable angina or myocardial infarction; thrombocytopenia； neutrophil reduction； malignant tumor; allergy to tocilizumab
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Xinlun Tian, M.D., 86-10-69155039, xinlun_t@sina.com
About this study
Official title: A Prospective, Randomized Controlled Study to Compare Efficacy and Safety of Intravenous 8mg/kg Tocilizumab Versus Regular Treatment for Severe Rapid Progressive Interstitial Lung Diseases (RP-ILD) Secondary to Systemic Diseases
There is no confirmed drug therapy for RP-ILD. Prognosis is poor of regular treatment. The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.
Read the detailed description
RP-ILD, also known as the acute exacerbation of interstitial lung disease, was defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest imaging or histopathology. It is rapidly progressive and life-threatening. Despite aggressive regular treatments with high-dose glucocorticoids in combination with immunosuppressant drugs such as cyclosporine, tacrolimus, or cyclophosphamide, the post-exacerbation mortality rates remain high. There is no confirmed drug therapy for RP-ILD. Recently, the exacerbation of interstitial lung diseases secondary to systemic diseases was proved to involve many inflammatory responses, so patients are more likely to benefit from immune regulation therapy. Tocilizumab is a monoclonal antibody that inhibits the binding of interleukin-6 (IL-6), a multifunctional cytokine that regulates the immune response and inflammation, to its receptor (IL-6R). The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.
- Being tested
- Tocilizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab. No Intervention: control, participants in control group will receive regular treatment. Receives: Drug: Tocilizumab |
| Control | No intervention | Participants in control group will receive regular treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose*
first dose: The tocilizumab group: the tocilizumab administered for the first time; The control group: the maximum dose of glucocorticoid administered for the first time
Measured: 3 months
Secondary outcomes (10)
Time to clinical stability
clinical stability was defined as on the first day that all of the following criteria are simultaneously achieved: (1) Participants can tolerate walking with or without oxygen therapy; (2) no wheeze; and (3) oxygen saturation >88% on room air.
Measured: 3 months
Survival rate after 3 months
Measured: 3 months
Length of stay in hospital
Measured: 3 months
Length of stay in ICU
Measured: 3 months
Changes of dyspnea index
Measured: 3 months
The occurrence of adverse events within 1, 3, 7, 14, 28 days and 3 months after the first dose
adverse events: sepsis, treatment-related hyperglycemia, gastrointestinal bleeding, hospital infection
Measured: 3 months
Changes of erythrocyte sedimentation rate, c-reactive protein or ferritin at baseline and on day 3, 7, 14, 28, month 3 after the first dose
Measured: 3 months
Computed tomography score
Measured: 3 months
Hospitalization cost
Measured: 3 months
Re-admission rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start22 Feb 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Progressive Interstitial Lung DiseasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are planned to be separated into two groups. 68 participants with severe RP-ILD secondary to systemic diseases will be randomly assigned to receive intravenous 8mg/kg tocilizumab or regular treatment.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinlun Tian, M.D., Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181397
- Sponsor's protocol ID
- JS-2679
- Status last verified
- Mar 2021
- First submitted
- 19 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol and clinical study report will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study to Compare Efficacy and Safety of Intravenous 8mg/kg Tocilizumab Versus Regular Treatment for Severe Rapid Progressive Interstitial Lung Diseases (RP-ILD) Secondary to Systemic Diseases
- ClinicalTrials.gov ID
- NCT05181397
- Acronym / sponsor ID
- JS-2679
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 6 Jan 2022 (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.
There is no confirmed drug therapy for RP-ILD. Prognosis is poor of regular treatment. The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.
Detailed description
RP-ILD, also known as the acute exacerbation of interstitial lung disease, was defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest imaging or histopathology. It is rapidly progressive and life-threatening. Despite aggressive regular treatments with high-dose glucocorticoids in combination with immunosuppressant drugs such as cyclosporine, tacrolimus, or cyclophosphamide, the post-exacerbation mortality rates remain high. There is no confirmed drug therapy for RP-ILD. Recently, the exacerbation of interstitial lung diseases secondary to systemic diseases was proved to involve many inflammatory responses, so patients are more likely to benefit from immune regulation therapy. Tocilizumab is a monoclonal antibody that inhibits the binding of interleukin-6 (IL-6), a multifunctional cytokine that regulates the immune response and inflammation, to its receptor (IL-6R). The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are planned to be separated into two groups. 68 participants with severe RP-ILD secondary to systemic diseases will be randomly assigned to receive intravenous 8mg/kg tocilizumab or regular treatment.
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: TocilizumabParticipants in tocilizumab group will receive intravenous 8mg/kg tocilizumab. No Intervention: control, participants in control group will receive regular treatment. |
| Control | No intervention | –Participants in control group will receive regular treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- RP-ILD, previous or concurrent diagnosis of systemic diseases
Key exclusion criteria (1 listed)
- pregnancy; uncontrolled pulmonary infections; severe cardiovascular, hepatic and renal dysfunction; unstable angina or myocardial infarction; thrombocytopenia； neutrophil reduction； malignant tumor; allergy to tocilizumab
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 |
|---|---|---|
| TocilizumabParticipants in tocilizumab group will receive intravenous 8mg/kg tocilizumab. | Drug | Tocilizumab |
Primary outcome
The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose*
Time frame: 3 months
first dose: The tocilizumab group: the tocilizumab administered for the first time; The control group: the maximum dose of glucocorticoid administered for the first time
10 secondary outcomes
Time to clinical stability
Time frame: 3 months
Survival rate after 3 months
Time frame: 3 months
Length of stay in hospital
Time frame: 3 months
Length of stay in ICU
Time frame: 3 months
Changes of dyspnea index
Time frame: 3 months
The occurrence of adverse events within 1, 3, 7, 14, 28 days and 3 months after the first dose
Time frame: 3 months
Changes of erythrocyte sedimentation rate, c-reactive protein or ferritin at baseline and on day 3, 7, 14, 28, month 3 after the first dose
Time frame: 3 months
Computed tomography score
Time frame: 3 months
Hospitalization cost
Time frame: 3 months
Re-admission rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: Yes. The protocol and clinical study report will be shared.
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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.
Xinlun Tian, M.D. study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab in people with Rapid Progressive Interstitial Lung Diseases, 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 1 inclusion and 1 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 6 Jan 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinlun Tian, M.D. (86-10-69155039, xinlun_t@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose* (time frame: 3 months). 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 6 Jan 2022.