Systemic Sclerosis (SSc)Phase 2NCT07925242
FAPI PET in Systemic Sclerosis Interstitial Lung Disease
A Phase 2 study testing FAPI tracer in people with Systemic Sclerosis (SSc) and Scleroderma, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is a phase II open-label efficacy and safety study to evaluate standard of care treatment response measured by PET imaging radiotracer 68Ga-FAPI-46 in 120 subjects with SSc-ILD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Scleroderma, Interstitial Lung Disease With Systemic Sclerosis
- What is being tested?
- FAPI tracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2030
- 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
- Ability to provide written informed consent.
- Male or female > 18 years of age at the screening visit.
- Meets the 2013 American College of Rheumatology (ACR)/EULAR Classification Criteria for SSc.
- ILD confirmed by thoracic high resolution computed tomography (HRCT) at the baseline visit.
- Initiated or will initiate a new ILD therapy within the last 3 months +/- 1 week prior to the screening visit.
- If enrolled in the FAPI/PET group, women of child-bearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnant test will be required.
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study.
- Active infectious lung disease.
- Current malignancy other than squamous or basal cell carcinoma.
- Current lung disease other than ILD (e.g., emphysema).
- Subjects must not have participated in another clinical trial with an investigational product within 90 days prior to enrollment and agree to abstain from such trials during the study.
- Prior allergic reaction to radiotracer 68Ga-FAPI-46.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA Division of Rheumatology
Los Angeles, California, 90095
About this study
Official title: PHASE II OPEN-LABEL EFFICACY AND SAFETY STUDY OF FIBROBLAST ACTIVATION PROTEIN α (FAP)-DIRECTED RADIOTRACER 68Ga-FAPI-46 AS A POSITRON EMISSION TOMOGRAPHY (PET) FUNCTIONAL RESPONSE BIOMARKER FOR SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
This is a phase II open-label efficacy and safety study to evaluate standard of care treatment response measured by PET imaging radiotracer 68Ga-FAPI-46 in 120 subjects with SSc-ILD.
- Being tested
- FAPI tracer
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI tracerDrug
68Ga-FAPI-46 will be used for the PET/CT for SSc ILD patients
| Study group | Role | What they receive |
|---|---|---|
| Receive PET Scan | Experimental | Not described Receives: Drug: FAPI tracer |
| Blood Draw Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction progressive pulmonary fibrosis (PPF) by evaluation of the change in uptake of radiotracer 68Ga-FAPI-46
This endpoint will evaluate whether the change in uptake of radiotracer 68Ga-FAPI-46 from baseline to 6 months of treatment predicts progressive pulmonary fibrosis (PPF) at 1 year according to American Thoracic Society guidelines.
Measured: 1 year
Secondary outcomes (1)
Prediction progressive pulmonary fibrosis (PPF) by evaluation of the change in the levels of specific blood-based biomarkers
This endpoint will evaluate whether the change in circulating biomarkers levels at 6 months predicts PPF at 1 year using the same definition above.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Elizabeth Volkmann, MD, MS, University of California, Los Angeles
- Investigators
- Elizabeth Volkmann, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925242
- Sponsor's protocol ID
- 25-1723
- Other IDs
- 1R01HL174555-01A1, 5R01HL174555-02
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- 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 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II OPEN-LABEL EFFICACY AND SAFETY STUDY OF FIBROBLAST ACTIVATION PROTEIN α (FAP)-DIRECTED RADIOTRACER 68Ga-FAPI-46 AS A POSITRON EMISSION TOMOGRAPHY (PET) FUNCTIONAL RESPONSE BIOMARKER FOR SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
- ClinicalTrials.gov ID
- NCT07925242
- Acronym / sponsor ID
- 25-1723
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 9 Nov 2026 (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 phase II open-label efficacy and safety study to evaluate standard of care treatment response measured by PET imaging radiotracer 68Ga-FAPI-46 in 120 subjects with SSc-ILD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive PET Scan | Experimental | Drug: FAPI tracer |
| Blood Draw Only | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide written informed consent.
- Male or female > 18 years of age at the screening visit.
- Meets the 2013 American College of Rheumatology (ACR)/EULAR Classification Criteria for SSc.
- ILD confirmed by thoracic high resolution computed tomography (HRCT) at the baseline visit.
- Initiated or will initiate a new ILD therapy within the last 3 months +/- 1 week prior to the screening visit.
Key exclusion criteria (7 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study.
- Active infectious lung disease.
- Current malignancy other than squamous or basal cell carcinoma.
- Current lung disease other than ILD (e.g., emphysema).
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 |
|---|---|---|
| FAPI tracer68Ga-FAPI-46 will be used for the PET/CT for SSc ILD patients | Drug | Receive PET Scan |
Primary outcome
Prediction progressive pulmonary fibrosis (PPF) by evaluation of the change in uptake of radiotracer 68Ga-FAPI-46
Time frame: 1 year
This endpoint will evaluate whether the change in uptake of radiotracer 68Ga-FAPI-46 from baseline to 6 months of treatment predicts progressive pulmonary fibrosis (PPF) at 1 year according to American Thoracic Society guidelines.
1 secondary outcome
Prediction progressive pulmonary fibrosis (PPF) by evaluation of the change in the levels of specific blood-based biomarkers
Time frame: 1 year
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 9 Nov 2026.
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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.
Elizabeth Volkmann, MD, MS principal investigator
University of California, Los Angeles
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 FAPI tracer in people with Systemic Sclerosis (SSc) and Scleroderma, run by University of California, Los Angeles 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 6 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: opening soon, as of the sponsor's last update on 9 Nov 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. 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 Nahal E Ghanoongooi, CRC, MPH (310-794-1638, nghanoongooi@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction progressive pulmonary fibrosis (PPF) by evaluation of the change in uptake of radiotracer 68Ga-FAPI-46 (time frame: 1 year). 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 9 Nov 2026.