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New pill could ease deadly lung pressure condition

NCT ID NCT07441278

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests an oral drug called NS-863 in 177 adults with pulmonary hypertension linked to interstitial lung disease (PH-ILD). Participants will receive either a low dose, high dose, or placebo for 24 weeks. The main goal is to see if the drug improves blood vessel resistance in the lungs and is safe.

What this could mean

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

Active substance
NS-863 (an oral drug)
What this could lead to
If successful, this could point toward a new oral treatment to improve blood flow in the lungs for people with PH-ILD.
What could go wrong
This is an early Phase 2 trial with only 177 participants, so results may not confirm benefit. The drug could also cause side effects or fail to improve outcomes.

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 177 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 to 80 years

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: Participants must meet all of the following criteria to be included in the trial: * Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and restrictions listed in the informed consent form (ICF). Participants must be able to read, comprehend, and write at a level sufficient to complete trial-related materials * Adult male or female participants 18 to 80 years of age at the time the ICF is signed * A confirmed diagnosis of the following WHO Group 3 PH based on computed tomography imaging, which demonstrates the following evidence of ILD performed within 6 months prior to starting the Treatment Period: 1. ILD 2. CPFE: only allowed for participants with 15% or less emphysema, and the extent of the ILD must be greater than that of the emphysema. Participants may have any form of ILD (including IIP, IPF, and connective tissue disease) or CPFE * Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria: 1. Participants receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, prostacyclin analogs or prostacyclin receptor agonists, and/or calcium channel blockers are eligible only if on a stable dose for at least 90 days prior to RHC at baseline and throughout the Screening Period. For infusion prostacyclin analogs, dose adjustment based on the participant's body weight is allowed per medical practice. 2. Participants on chronic medication for underlying lung disease (ie, pirfenidone, etc.) are eligible only if on a stable dose for at least 90 days prior to RHC at baseline and throughout the Screening Period 3. Participants receiving treatment with oxygen therapy are eligible only if beginning for at least 30 days prior to RHC at baseline and throughout the Screening Period, and on a stable dose of oxygen for 30 minutes before RHC * Valid 6MWD * Women of childbearing potential (WOCBP) must have a negative pregnancy test before receiving the trial treatment and must agree to use contraception from the Screening Visit to at least 30 days after the last dose of the trial treatment. Male participants who could potentially cause pregnancy must agree to use contraception from the Screening Visit to at least 90 days after the last dose of the trial treatment to avoid pregnancy in their partners * Able to complete the scheduled visits and follow the instructions of the investigator Exclusion Criteria: Participants meeting any of the following criteria at the Screening Visit or baseline are ineligible to participate in this trial: * Have a diagnosis of PAH or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3 * Have evidence of clinically significant left-sided heart disease, as defined by: a. LVEF \<40% Notes: Participants with abnormal LV function attributable entirely to impaired LV filling due to the effects of RV overload (ie, RV hypertrophy and/or dilatation) will not be excluded * Receiving \> 6 L/min of oxygen supplementation by any mode of delivery at rest at baseline * Moderate or severe liver, renal, blood, or psychiatric disease: 1. Moderate and severe hepatic impairment by the Child-Pugh scoring system (Class B and Class C) 2. Moderate and severe renal impairment by estimated glomerular filtration rate (eGFR) \<60 mL/min/m2 3. Have mental disorders or other conditions that make it difficult to follow the protocol * History of clinically significant (per investigator's judgment) drug or alcohol abuse disorder within the last 6 months * Have mental disorders or other conditions that make it difficult to follow the protocol * History of calculus urinary * Have a deterioration of underlying disease or a lung or upper respiratory tract infection within 30 days prior to baseline * Initiation of pulmonary rehabilitation within 12 weeks prior to baseline * At the time of consent, more than 1 year has passed since registration for lung transplantation, or surgery related to PH treatment is scheduled * Have diseases or symptoms that limit evaluation of 6MWT (eg, peripheral vascular disease, musculoskeletal disorders, and obesity) * Participants who have participated in another clinical trial involving a drug or medical device, or have received treatment with an investigational product (including investigational formulations of marketed products), within 30 days prior to the Screening Visit or within 5 terminal phase half-lives of the investigational product, whichever is longer * Life expectancy is less than 6 months * Acute pulmonary embolism within 90 days prior to baseline * Current cigarette or e-cigarette smokers or those who have quit within the past 6 months, with a history of ≥20 pack-years smoking * Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation * Use of dual platelet inhibitor therapy * Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with trial participation or trial treatment administration * Have a history of allergies to the excipients in the trial treatment * Known human immunodeficiency virus (HIV) positive status * Active hepatitis due to hepatitis B virus or hepatitis C virus * Use of any protocol prohibited medications. * Receipt of any live vaccine within 4 weeks prior to the first dose of trial treatment or expected need for live vaccination during trial participation, including at least 4 weeks after the last dose of trial treatment * The investigator has judged the participant as unwilling or unable to * comply with the protocol * Other concurrent disease and/or medical condition that, in the judgment of the investigator, may put the participant at risk or may influence the results of the trial or the participant's ability to complete the entire duration of the trial

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.