Interstitial Lung DiseasePhase 2ILD-DLCONCT05079126
Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
A Phase 2 study testing Trans Sodium Crocetinate in people with Interstitial Lung Disease, run by Diffusion Pharmaceuticals Inc at 1 site in United States.
Trial summary
This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Trans Sodium Crocetinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 27 May 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, age 30 to 85 years at screening
- Able to provide informed consent and agree to adhere to all study visits and requirements
- Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug
- Established diagnosis of ILD (clinical, radiographic, or histologic)
- SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air
- Free of any active cardiovascular or neuromuscular disease, at PI discretion
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- Clinically stable disease with no major medication changes in the last 4 weeks
- Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months)
- DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months)
- Sars-CoV-2 negative at screening
Who cannot join
- Known allergy to study medication
- Pregnancy or lactation
- Current smoker
- Inability to perform pulmonary function testing
- Active infection at screening or day of study visit
- Known pulmonary hypertension (PH) requiring PH-specific treatment
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- AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN
- Received any investigational medicine (IMP) within past 30 days
- Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant.
- Current alcohol or substance abuse
- Known active or latent hepatitis B or C
- History of end-stage liver or renal disease
- Positive COVID test anytime within 3 months of screening. Note:
- Patients who were previously vaccinated for COVID are allowed
- History of venous thromboembolic disease
- History of acute or chronic ophthalmologic conditions currently requiring treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.
- Conditions
- Interstitial Lung Disease
- Being tested
- Trans Sodium Crocetinate, Placebo
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Sodium CrocetinateDrug
Single IV Bolus
PlaceboDrug
Single IV Bolus
| Study group | Role | What they receive |
|---|---|---|
| 2.5 mg/kg Trans Sodium Crocetinate | Experimental | Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Receives: Drug: Trans Sodium Crocetinate |
| Placebo | Placebo comparator | Subjects will receive a single IV bolus dose of 7 mL Normal Saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD
Compare the proportion of patients who achieve a prespecified level of improvement in DLCO 30 minutes after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.
Measured: 30 minutes
Secondary outcomes (3)
Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD
Compare the proportion of patients who achieve a pre-specified level of improvement in 6 minute walk test (6MWT) after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.
Measured: 60 minutes
Change from baseline in HRR after each 6MWT
Compare the proportion of patients who achieve a pre-specified level of improvement in heart rate recovery (HRR) after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.
Measured: 60 minutes
Change from baseline in the Borg Scale after the 6MWT
Compare the proportion of patients who achieve a pre-specified level of improvement in the Borg dyspnea scale after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start2 Dec 2021
- Primary completion25 May 2022
- Study completion27 May 2022
Why it stopped: Due to, among other things, positive results from the 200-302 trial, the trial has been terminated early. Resources shifted to new 200-208 GBM trial using information gained from 200-302.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diffusion Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079126
- Sponsor's protocol ID
- 100-601
- Acronym
- ILD-DLCO
- Status last verified
- Aug 2022
- First submitted
- 4 Oct 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05079126
- Acronym / sponsor ID
- ILD-DLCO / 100-601
- Conditions
- Interstitial Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to, among other things, positive results from the 200-302 trial, the trial has been terminated early. Resources shifted to new 200-208 GBM trial using information gained from 200-302.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Diffusion Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 15 Oct 2021 (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 randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5 mg/kg Trans Sodium Crocetinate | Experimental | Drug: Trans Sodium CrocetinateSubjects will receive a single IV bolus dose of 2.5 mg/kg TSC. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a single IV bolus dose of 7 mL Normal Saline. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female, age 30 to 85 years at screening
- Able to provide informed consent and agree to adhere to all study visits and requirements
- Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug
- Established diagnosis of ILD (clinical, radiographic, or histologic)
- SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air
Key exclusion criteria (16 listed)
- Known allergy to study medication
- Pregnancy or lactation
- Current smoker
- Inability to perform pulmonary function testing
- Active infection at screening or day of study visit
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 |
|---|---|---|
| Trans Sodium CrocetinateSingle IV Bolus | Drug | 2.5 mg/kg Trans Sodium Crocetinate |
| PlaceboSingle IV Bolus | Drug | Placebo |
Primary outcome
Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD
Time frame: 30 minutes
Compare the proportion of patients who achieve a prespecified level of improvement in DLCO 30 minutes after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.
3 secondary outcomes
Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD
Time frame: 60 minutes
Change from baseline in HRR after each 6MWT
Time frame: 60 minutes
Change from baseline in the Borg Scale after the 6MWT
Time frame: 60 minutes
Results and safety
The study was stopped early (reason given: Due to, among other things, positive results from the 200-302 trial, the trial has been terminated early. Resources shifted to new 200-208 GBM trial using information gained from 200-302.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Trans Sodium Crocetinate in people with Interstitial Lung Disease, run by Diffusion Pharmaceuticals Inc 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 10 Aug 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 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?
The study was stopped early (reason given: Due to, among other things, positive results from the 200-302 trial, the trial has been terminated early. Resources shifted to new 200-208 GBM trial using information gained from 200-302.). Results are not available in the source record.
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 at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD (time frame: 30 minutes). 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 10 Aug 2022.