Trial · NCT07886554
LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
NCT07886554, Phase 2, Not yet recruiting, IRulya Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH). Trials, record NCT07886554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07886554
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
- NCT number
- NCT07886554
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- IRulya Therapeutics Inc.
- Conditions
- Sarcoidosis Associated Pulmonary Hypertension
- Interventions
- Placebo, LAM-001, LAM-001
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pulmonary Vascular Resistance (PVR) at 24 weeks | 24 weeks | Change from baseline in PVR at 24 weeks adjudicated by the RHC core laboratory |
| Secondary | Change in Six minute walk distance (6MWD) at 24 weeks | 24 weeks | Change in 6MWD at 24 weeks |
| Secondary | Time to Clinical Worsening (TCW) | 24 weeks | TCW (from time of randomization until study treatment discontinuation due to clinical worsening) using predefined criteria. Clinical worsening is defined as one of the following: * Death * Lung transplantation or Heart-Lung transplantation * Hospitalization related to worsening respiratory status/respiratory decompensation (\>24 hours) * PH symptoms that require the addition of or increase in dose \> 10% of a PH disease-specific medication * Symptomatic \>10% decline from baseline FVC confirmed with repeat testing * Worsened WHO functional class AND * Symptomatic \>15% decline in 6MWD from baseline directly related to the disease (at 2 consecutive visits at least 24 hours apart) |
| Secondary | The number of clinical worsening events at 24 weeks | 24 weeks | The number of clinical worsening events at 24 weeks |
| Secondary | Change in NT-proBNP at 24 weeks | 24 weeks | Change in NT-proBNP at 24 weeks |
| Secondary | Changes in FVC and DLCO and TLV/TLC (if available) at 24 weeks | 24 weeks | Change in FVC, TLV/TLC, and DLCO at 24 weeks |
| Secondary | To determine if LAM-001 treatment is safe and well tolerated compared to placebo | 24 weeks | Frequency, incidence and severity of * Adverse events (AEs) * Local and systemic adverse events of special interest (AESI) * Treatment emergent adverse events (TEAEs) * Serious adverse events (SAEs) |
| Secondary | To characterize the dose-response relationship of LAM-001 to identify the optimal therapeutic dose for Phase 3 | 24 weeks | PK analysis of LAM-001 (Maximum Plasma Concentration \[Cmax\]) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07886554
GET https://conductscience.org/api/trials/v1/NCT07886554/registered