Raynaud's Phenomenon Secondary to Systemic SclerosisPhase 2RE-WARMNCT07748000
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
A Phase 2 study testing LIQ861 (treprostinil) inhalation powder - Dose Titration Arm and LIQ861 (treprostinil) inhalation powder - fixed dose arm in people with Raynaud's Phenomenon Secondary to Systemic Sclerosis, run by Liquidia Technologies, Inc..
Trial summary
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually triggered by cold or stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Raynaud's Phenomenon Secondary to Systemic Sclerosis
- What is being tested?
- LIQ861 (treprostinil) inhalation powder - Dose Titration Arm and LIQ861 (treprostinil) inhalation powder - fixed dose arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to Mar 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
- Male or female ≥18 years of age
- Classification of SSc per the 2013 ACR/EULAR criteria.
- Diagnosis or history of Raynaud's phenomenon
- Minimum of 12 (maximum 100) symptomatic RP attacks documented in the ePRO diary over ≥4 separate days
Who cannot join
- ≥3 digital ulcers at screening; a new digital ulcer between screening and randomization; gangrene or amputation within 6 months; digital ulcer infection within 3 months.
- History of cervical/digital sympathectomy or hand botulinum toxin injections within 90 days (or planned during the study).
- Clinically significant bleeding risk, coagulation disorder, or platelet count <100 x 10^9/L.
- Known WHO Group 1-5 pulmonary hypertension; significant obstructive (FEV1 <65%) or restrictive (FVC <60%) lung disease; need for supplemental oxygen; severe asthma.
- Severe uncontrolled hypertension (SBP ≥160 and/or DBP >100 mmHg) or severe hypotension (SBP <85 mmHg).
- Any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonist within 12 weeks of screening; initiation/dose change of vasodilators within 4 weeks of screening; non-topical CYP2C8 inhibitors/inducers (unless discontinued for >5 half-lives before randomization).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2a Randomized, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of LIQ861 in Participants With Systemic Sclerosis Experiencing Symptomatic Raynaud's Phenomenon Attacks / RE-WARM
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually triggered by cold or stress. This open-label study is testing an inhaled powder form of treprostinil (LIQ861) to find out which doses can be taken safely and comfortably by adults with SSc who have frequent symptomatic RP attacks. About 75 adults will be randomly assigned (2 to 1) to either a dose-titration group or a fixed low-dose group. The study also explores whether treatment reduces the number, severity, and impact of RP attacks. The main goal is to identify tolerated dose(s).
- Being tested
- LIQ861 (treprostinil) inhalation powder - Dose Titration Arm, LIQ861 (treprostinil) inhalation powder - fixed dose arm
- Keywords
- systemic sclerosis, Raynaud's phenomenon, Digital ischemia, treprostinil, prostacyclin analog, dry powder inhaler, vasodilator
- Medical subject headings
- Scleroderma, Systemic, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIQ861 (treprostinil) inhalation powder - Dose Titration ArmCombination product
Also called treprostinil inhalation powder, YUTREPIA
Treprostinil inhalation powder supplied as capsules in strengths of 26.5, 53, 79.5, and 106 mcg, administered by oral inhalation QID (approximately 3-4 hours apart during waking hours) for 21 days using the RS00 Model 8 Monodose DPI
LIQ861 (treprostinil) inhalation powder - fixed dose armCombination product
Also called treprostinil inhalation powder, YUTREPIA
Treprostinil inhalation powder supplied as 26.5 mcg capsules administered by oral inhalation QID (approximately 3-4 hours apart during waking hours) for 21 days using the RS00 Model 8 Monodose DPI
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: LIQ861 Dose Titration Arm | Experimental | Not described Receives: Combination Product: LIQ861 (treprostinil) inhalation powder - Dose Titration Arm |
| Arm 2: LIQ861 Fixed Dose | Experimental | Not described Receives: Combination Product: LIQ861 (treprostinil) inhalation powder - fixed dose arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant incidence of tolerated dose(s) of LIQ861 defined as a dose level or dose regimen at which ≥80% of participants complete the Treatment Period with ≥80% compliance without permanent discontinuation of LIQ861 due to a TEAE
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start26 Oct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's Phenomenon Secondary to Systemic SclerosisStudies 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
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liquidia Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748000
- Sponsor's protocol ID
- LTI-202
- Acronym
- RE-WARM
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of LIQ861 in Participants With Systemic Sclerosis Experiencing Symptomatic Raynaud's Phenomenon Attacks / RE-WARM
- ClinicalTrials.gov ID
- NCT07748000
- Acronym / sponsor ID
- RE-WARM / LTI-202
- Keywords
- systemic sclerosis, Raynaud's phenomenon, Digital ischemia, treprostinil, prostacyclin analog, dry powder inhaler, vasodilator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Liquidia Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Aug 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.
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually triggered by cold or stress. This open-label study is testing an inhaled powder form of treprostinil (LIQ861) to find out which doses can be taken safely and comfortably by adults with SSc who have frequent symptomatic RP attacks. About 75 adults will be randomly assigned (2 to 1) to either a dose-titration group or a fixed low-dose group. The study also explores whether treatment reduces the number, severity, and impact of RP attacks. The main goal is to identify tolerated dose(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: LIQ861 Dose Titration Arm | Experimental | Combination Product: LIQ861 (treprostinil) inhalation powder - Dose Titration Arm |
| Arm 2: LIQ861 Fixed Dose | Experimental | Combination Product: LIQ861 (treprostinil) inhalation powder - fixed dose arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years of age
- Classification of SSc per the 2013 ACR/EULAR criteria.
- Diagnosis or history of Raynaud's phenomenon
- Minimum of 12 (maximum 100) symptomatic RP attacks documented in the ePRO diary over ≥4 separate days
Key exclusion criteria (6 listed)
- ≥3 digital ulcers at screening; a new digital ulcer between screening and randomization; gangrene or amputation within 6 months; digital ulcer infection within 3 months.
- History of cervical/digital sympathectomy or hand botulinum toxin injections within 90 days (or planned during the study).
- Clinically significant bleeding risk, coagulation disorder, or platelet count <100 x 10^9/L.
- Known WHO Group 1-5 pulmonary hypertension; significant obstructive (FEV1 <65%) or restrictive (FVC <60%) lung disease; need for supplemental oxygen; severe asthma.
- Severe uncontrolled hypertension (SBP ≥160 and/or DBP >100 mmHg) or severe hypotension (SBP <85 mmHg).
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 |
|---|---|---|
| LIQ861 (treprostinil) inhalation powder - Dose Titration ArmAlso: treprostinil inhalation powder, YUTREPIATreprostinil inhalation powder supplied as capsules in strengths of 26.5, 53, 79.5, and 106 mcg, administered by oral inhalation QID (approximately 3-4 hours apart during waking hours) for 21 days using the RS00 Model 8 Monodose DPI | Combination product | Arm 1: LIQ861 Dose Titration Arm |
| LIQ861 (treprostinil) inhalation powder - fixed dose armAlso: treprostinil inhalation powder, YUTREPIATreprostinil inhalation powder supplied as 26.5 mcg capsules administered by oral inhalation QID (approximately 3-4 hours apart during waking hours) for 21 days using the RS00 Model 8 Monodose DPI | Combination product | Arm 2: LIQ861 Fixed Dose |
Primary outcome
Participant incidence of tolerated dose(s) of LIQ861 defined as a dose level or dose regimen at which ≥80% of participants complete the Treatment Period with ≥80% compliance without permanent discontinuation of LIQ861 due to a TEAE
Time frame: 21 days
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 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIQ861 (treprostinil) inhalation powder - Dose Titration Arm and LIQ861 (treprostinil) inhalation powder - fixed dose arm in people with Raynaud's Phenomenon Secondary to Systemic Sclerosis, run by Liquidia Technologies, Inc..
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 4 inclusion and 6 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Liquidia Point of Contact (1-888-241-6906, LiquidiaStudies@liquidia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant incidence of tolerated dose(s) of LIQ861 defined as a dose level or dose regimen at which ≥80% of participants complete the Treatment Period with ≥80% compliance without permanent discontinuation of LIQ861 due to a TEAE (time frame: 21 days). 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 Aug 2026.