Interstitial Lung DiseasePhase 2NCT05892614
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
A Phase 2 study testing efzofitimod 450 mg and efzofitimod 270 mg in people with Interstitial Lung Disease, run by aTyr Pharma, Inc. at 15 sites in United States.
Trial summary
This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- efzofitimod 450 mg and efzofitimod 270 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 15 sitesUnited States
- Study dates
- 26 Oct 2023to Apr 2026
- 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
- Diagnosis of SSc based on ACR/ EULAR criteria (2013)
- Overall duration of SSc < 84 months from the first non-Raynaud symptom manifestation prior to Day 1
- HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement > 10%
- Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
- MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to mycophenolates (in discussion with the Medical Monitor): treatment with maximum tolerated dose of MMF is acceptable, if < 2 gm/day, provided the cumulative duration of dosing has exceeded 3 months, OR An adequate dose and duration of an alternate immunosuppressant with a stable dose for the 4 weeks prior to baseline is also allowed.
Who cannot join
- Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio < 0.7
- Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
- HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
- Treatment with corticosteroids (> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
- Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate [MTX], azathioprine [AZA], or leflunomide)
- Any treatment in the 12 months prior to Day 1 with any of the following: rituximab, intravenous immune globulin (IVIG), tocilizumab, cyclophosphamide, pirfenidone, tyrosine-kinase inhibitors (e.g., imatinib, nilotinib, dasatinib)
- Rheumatic autoimmune disease other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products
- History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
aTyr Investigative Site
Charleston, South Carolina, 29425
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Chicago, Illinois, 60153
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Chicago, Illinois, 60611
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Chicago, Illinois, 60612
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Cleveland, Ohio, 44195
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Dallas, Texas, 75204
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Houston, Texas, 77204
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Los Angeles, California, 90024
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Miami, Florida, 33146
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
New Orleans, Louisiana, 70115
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
New York, New York, 10027
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Oklahoma City, Oklahoma, 73104
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Richmond, Virginia, 23284
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
Salt Lake City, Utah, 84112
877-689-4494, SScILD@cssienroll.com
- Recruiting
aTyr Investigative Site
San Diego, California, 92093
877-689-4494, SScILD@cssienroll.com
About this study
Official title: Randomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20. Part B is an optional open-label extension to Part A in which participants can receive 450 mg efzofitimod every 4 weeks for 6 doses.
- Conditions
- Interstitial Lung Disease
- Being tested
- efzofitimod 450 mg, efzofitimod 270 mg, Placebo
- Keywords
- ILD, SSc-ILD, Interstitial Lung Disease, lung inflammation, fibrosis, pulmonary function, efzofitimod, systemic sclerosis
- Medical subject headings
- Lung Diseases, Interstitial, Pneumonia, Fibrosis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efzofitimod 450 mgDrug
IV infusion over approximately 60 minutes every 4 weeks
efzofitimod 270 mgDrug
IV infusion over approximately 60 minutes every 4 weeks
PlaceboDrug
IV infusion over approximately 60 minutes every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| efzofitimod 450 mg | Experimental | Administered IV infusion Receives: Drug: efzofitimod 450 mg |
| efzofitimod 270 mg | Experimental | Administered IV infusion Receives: Drug: efzofitimod 270 mg |
| Placebo | Placebo comparator | Administered IV infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in forced vital capacity (FVC) in mL
Measured: 24 weeks
Annual rate of decline in FVC in mL
Measured: 24 weeks
Annual rate of decline in FVC in percent predicted
Measured: 24 weeks
Change in HRCT fibrosis score
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start26 Oct 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- aTyr Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Carey, Study director, aTyr Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892614
- Sponsor's protocol ID
- ATYR1923-C-005
- Status last verified
- May 2025
- First submitted
- 12 May 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
- ClinicalTrials.gov ID
- NCT05892614
- Acronym / sponsor ID
- ATYR1923-C-005
- Conditions
- Interstitial Lung Disease
- Keywords
- ILD, SSc-ILD, Interstitial Lung Disease, lung inflammation, fibrosis, pulmonary function, efzofitimod, systemic sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- aTyr Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 Jun 2023 (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.
This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20. Part B is an optional open-label extension to Part A in which participants can receive 450 mg efzofitimod every 4 weeks for 6 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| efzofitimod 450 mg | Experimental | Drug: efzofitimod 450 mgAdministered IV infusion |
| efzofitimod 270 mg | Experimental | Drug: efzofitimod 270 mgAdministered IV infusion |
| Placebo | Placebo comparator | Drug: PlaceboAdministered IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of SSc based on ACR/ EULAR criteria (2013)
- Overall duration of SSc < 84 months from the first non-Raynaud symptom manifestation prior to Day 1
- HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement > 10%
- Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
- MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to mycophenolates (in discussion with the Medical Monitor): treatment with maximum tolerated dose of MMF is acceptable, if < 2 gm/day, provided the cumulative duration of dosing has exceeded 3 months, OR An adequate dose and duration of an alternate immunosuppressant with a stable dose for the 4 weeks prior to baseline is also allowed.
Key exclusion criteria (8 listed)
- Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio < 0.7
- Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
- HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
- Treatment with corticosteroids (> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
- Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate [MTX], azathioprine [AZA], or leflunomide)
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 |
|---|---|---|
| efzofitimod 450 mgIV infusion over approximately 60 minutes every 4 weeks | Drug | efzofitimod 450 mg |
| efzofitimod 270 mgIV infusion over approximately 60 minutes every 4 weeks | Drug | efzofitimod 270 mg |
| PlaceboIV infusion over approximately 60 minutes every 4 weeks | Drug | Placebo |
Primary outcome
Absolute change from baseline in forced vital capacity (FVC) in mL
Time frame: 24 weeks
Annual rate of decline in FVC in mL
Time frame: 24 weeks
Annual rate of decline in FVC in percent predicted
Time frame: 24 weeks
Change in HRCT fibrosis score
Time frame: Baseline to Week 24
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 7 May 2025.
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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.
Lisa Carey study director
aTyr Pharma, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing efzofitimod 450 mg and efzofitimod 270 mg in people with Interstitial Lung Disease, run by aTyr Pharma, Inc. at 15 sites 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Contact aTyr Pharma Clinical Research (877-215-5731, clinicaltrials@atyrpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in forced vital capacity (FVC) in mL (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 7 May 2025.