Diaphragm InjuryPhase 2NCT03681275
Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
A Phase 2 study testing Tofacitinib 10 MG [Xeljanz] in people with Diaphragm Injury, run by Stanford University at 1 site in United States.
Trial summary
We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Injury
- What is being tested?
- Tofacitinib 10 MG [Xeljanz]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2019to 31 Aug 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing esophagectomy
Who cannot join
- Patients with more than mild pulmonary dysfunction
- Patients with any neuromuscular disease that might compromise diaphragm function
- Patients with abnormal liver or kidney function
- Patients taking any immunosuppressant medication (including prednisone) or antifungal medications
- History of tuberculosis
- Weight loss of >5% of body weight over previous 6 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.
- Conditions
- Diaphragm Injury
- Being tested
- Tofacitinib 10 MG [Xeljanz], Placebo to match Tofacitinib
- Keywords
- Ventilator-induced Diaphragm Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 10 MG [Xeljanz]Drug
Also called XELJANZ
administered twice daily for two days
Placebo to match TofacitinibDrug
administered twice daily for two days
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Experimental | Patient will receive two days treatment with tofacitinib prior to the surgery. Receives: Drug: Tofacitinib 10 MG [Xeljanz] |
| Placebo | Placebo comparator | Patient will receive two days treatment with placebo prior to the surgery. Receives: Drug: Placebo to match Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition
Change in the force deficit that develops between the first and second muscle biopsies in the drug-treated vs. placebo groups
Measured: 5-6 years
Secondary outcomes (1)
Increase in muscle strength due to JAK inhibition
Difference in force generated by muscle biopsies taken at time point 1 (pre-mechanical ventilation) from the drug-treated vs placebo groups
Measured: 4-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start3 Sep 2019
- Primary completion31 Aug 2026
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diaphragm InjuryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joseph B. Shrager, MD, Stanford University
- Investigators
- Joseph Shrager, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681275
- Sponsor's protocol ID
- IRB-47826
- Other IDs
- R01HL148185
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2018
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Publications
Shrager JB, Wang Y, Lee M, Nesbit S, Trope W, Konsker H, Fatodu E, Berry MS, Poulstides G, Norton J, Burdon T, Backhus L, Cooke R, Tang H. Rationale and design of a mechanistic clinical trial of JAK inhibition to prevent ventilator-induced diaphragm dysfunction. Respir Med. 2021 Nov-Dec;189:106620. doi: 10.1016/j.rmed.2021.106620. Epub 2021 Sep 21.
PubMed 34655959Shrager JB, Randle R, Lee M, Ahmed SS, Trope W, Lui N, Poultsides G, Liou D, Visser B, Norton JA, Nesbit SM, He H, Kapula N, Wallen B, Fatodu E, Sadeghi CA, Konsker HB, Elliott I, Guenthart B, Backhus L, Cooke R, Berry M, Tang H. JAK inhibition with tofacitinib rapidly increases contractile force in human skeletal muscle. Life Sci Alliance. 2024 Aug 9;7(11):e202402885. doi: 10.26508/lsa.202402885. Print 2024 Nov.
PubMed 39122555
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
- ClinicalTrials.gov ID
- NCT03681275
- Acronym / sponsor ID
- IRB-47826
- Conditions
- Diaphragm Injury
- Keywords
- Ventilator-induced Diaphragm Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Sep 2018 (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.
We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Experimental | Drug: Tofacitinib 10 MG [Xeljanz]Patient will receive two days treatment with tofacitinib prior to the surgery. |
| Placebo | Placebo comparator | Drug: Placebo to match TofacitinibPatient will receive two days treatment with placebo prior to the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing esophagectomy
Key exclusion criteria (7 listed)
- Patients with more than mild pulmonary dysfunction
- Patients with any neuromuscular disease that might compromise diaphragm function
- Patients with abnormal liver or kidney function
- Patients taking any immunosuppressant medication (including prednisone) or antifungal medications
- History of tuberculosis
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 |
|---|---|---|
| Tofacitinib 10 MG [Xeljanz]Also: XELJANZadministered twice daily for two days | Drug | Tofacitinib |
| Placebo to match Tofacitinibadministered twice daily for two days | Drug | Placebo |
Primary outcome
Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition
Time frame: 5-6 years
Change in the force deficit that develops between the first and second muscle biopsies in the drug-treated vs. placebo groups
1 secondary outcome
Increase in muscle strength due to JAK inhibition
Time frame: 4-5 years
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 5 Oct 2026.
- Background: PubMed 34655959Shrager JB, Wang Y, Lee M, Nesbit S, Trope W, Konsker H, Fatodu E, Berry MS, Poulstides G, Norton J, Burdon T, Backhus L, Cooke R, Tang H. Rationale and design of a mechanistic clinical trial of JAK inhibition to prevent ventilator-induced diaphragm dysfunction. Respir Med. 2021 Nov-Dec;189:106620. doi: 10.1016/j.rmed.2021.106620. Epub 2021 Sep 21.
- Background: PubMed 39122555Shrager JB, Randle R, Lee M, Ahmed SS, Trope W, Lui N, Poultsides G, Liou D, Visser B, Norton JA, Nesbit SM, He H, Kapula N, Wallen B, Fatodu E, Sadeghi CA, Konsker HB, Elliott I, Guenthart B, Backhus L, Cooke R, Berry M, Tang H. JAK inhibition with tofacitinib rapidly increases contractile force in human skeletal muscle. Life Sci Alliance. 2024 Aug 9;7(11):e202402885. doi: 10.26508/lsa.202402885. Print 2024 Nov.
- Individual participant dataSharing planned: No. No plan to share IPD.
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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.
Joseph Shrager, MD principal investigator
Stanford University
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 Tofacitinib 10 MG [Xeljanz] in people with Diaphragm Injury, run by Stanford University at 1 site in United States.
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 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: under way, not looking for participants, as of the sponsor's last update on 5 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 United States. 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?
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?
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?
Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition (time frame: 5-6 years). 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 NCT03681275, which also lists 2 linked publications.
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 5 Oct 2026.