LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

StatusRecruiting
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Jul 16, 2027 → Mar 2028
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from IRulya Therapeutics Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: OrphAI Therapeutics to IRulya Therapeutics Inc.
    • Trial sites reduced: 32 → 4 locations
    • Eligibility criteria expanded, about 167 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Primary completion pushed from Jul 16, 2027 to Mar 2028 Show 4 more changesShow less
    • Trial sites expanded: 3 → 32 locations
    • Study completion pushed from Aug 30, 2028 to Feb 2029
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 2 of 6 entries
  3. Primary endpoint(s) modified
    • Secondary endpoints: 4 to 6
    • Study description shortened, about 1 word
    v13
  4. Trial status changed: Active, Not Recruiting → Recruiting
    • Site details revised at 3 of 3 sites
    v12
  5. Enrollment target: 10 to 85v11 Show 11 more changesShow less
    • Primary completion date: May 16, 2025 to Jul 16, 2027
    • Start date: Apr 3, 2023 to Aug 30, 2023
    • Primary endpoints: 1 to 2
    • Study sites: 4 to 3
    • Study completion date: Sep 30, 2027 to Aug 30, 2028
    • Interventions: LAM-001 (Drug) to LAM-001 (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 112 words
    • Secondary endpoints: 19 to 4
    • Study description expanded, about 99 words
    • Study arms: 1 to 3
    • Study title expanded, about 1 word
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv10 Show 4 more changesShow less
    • Enrollment target: estimated 15 to confirmed 10
    • Study sites: 5 to 4
    • Primary completion date changed from estimate of Sep 30, 2025 to May 16, 2025
    • Study completion date: Oct 30, 2026 to Sep 30, 2027
  2. Primary completion date: Dec 31, 2024 to Sep 30, 2025v9 Show 5 more changesShow less
    • Study completion date: Dec 31, 2025 to Oct 30, 2026
    • Eligibility criteria expanded, about 104 words
    • Secondary endpoints revised (19)
    • Study description revised
    • Site contacts updated at 1 of 5 sites
  3. Study sites: 6 to 5v8
  4. Study sites: 3 to 6v7
  5. Study sites: 2 to 3
    • Eligibility criteria shortened, about 39 words
    • Study description shortened, about 2 words
    v6
  6. Primary completion date: Feb 28, 2024 to Dec 31, 2024v5 Show 6 more changesShow less
    • Study sites: 1 to 2
    • Study completion date: Feb 28, 2025 to Dec 31, 2025
    • Eligibility criteria shortened, about 19 words
    • Secondary endpoints revised (19)
    • Study description shortened, about 7 words
    • Study title expanded, about 1 word
  7. Re-verified, no change to tracked fieldsv4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 31, 2023 to Apr 3, 2023
    • Site details revised
    v3
  9. Secondary endpoints: 18 to 19v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LAM-001 in Adults with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD).
Trial Details
NCT Number NCT05798923
Lead Sponsor IRulya Therapeutics Inc.
Conditions
(from sponsor)		 Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Related terms Hypoxia, Lung Diseases, Interstitial
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov