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Can an inhaled powder calm the painful Cold-Finger attacks of scleroderma?

NCT ID NCT07748000

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests an inhaled powder called LIQ861 (treprostinil) in adults with scleroderma who have frequent, painful Raynaud's attacks—episodes where fingers or toes turn color and become numb or tingly. About 75 participants will be randomly assigned to receive either a dose that gradually increases or a fixed low dose, to see which doses are safe and comfortable. The study also looks at whether the treatment reduces the number, severity, and impact of these attacks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LIQ861 (treprostinil) inhalation powder
What this could lead to
If it works, this could offer a new way to reduce the frequency and severity of painful Raynaud's attacks in people with scleroderma, improving daily comfort and quality of life.
What could go wrong
This is an early (phase 2) study with a small number of participants, so results may not apply broadly. The treatment may cause side effects or may not effectively reduce attacks.
Why investors are watching

Liquidia is testing LIQ861, an inhaled powder form of treprostinil, in patients with systemic sclerosis who have frequent Raynaud's attacks. This phase 2a study aims to find safe and tolerable doses, and it also tracks whether the drug reduces the number and severity of attacks. For a small company, this readout matters because it could expand LIQ861's use beyond its current focus into a rare disease with few treatment options.

If it works: If the trial shows LIQ861 is well tolerated and reduces Raynaud's attacks, Liquidia could gain a new market in systemic sclerosis. That would broaden its product pipeline and strengthen its position as a specialty drug developer.

If it fails: The trial could fail to show a clear benefit or reveal safety issues, which would set back Liquidia's plans for this drug. Trials in rare diseases often miss their goals, so a negative result would likely hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * ≥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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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