NCT05975983 Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
| NCT ID | NCT05975983 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | InSilico Medicine Hong Kong Limited |
| Condition | Idiopathic Pulmonary Fibrosis (IPF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-02-08 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this revised Phase IIa study is to demonstrate safety of INS018\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged ≥40 years based on the date of the written informed consent form 2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines 3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation 4. Meeting all of the following criteria during the screening period: 1. FVC ≥40% predicted normal 2. DLCO corrected for Hgb ≥25% and \<80% predicted normal 3. Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value Exclusion Criteria: 1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator 2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study 3. Female patients who are pregnant or nursing 4. Abnormal ECG findings
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05975983 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Idiopathic Pulmonary Fibrosis (IPF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05975983 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05975983 currently recruiting?
Yes, NCT05975983 is actively recruiting participants. Contact the research team at Insilico-Clinicaltrial@insilico.ai for enrollment information.
Where is the NCT05975983 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, Los Angeles, United States, Celebration, United States and 8 additional locations.
Who is sponsoring the NCT05975983 clinical trial?
NCT05975983 is sponsored by InSilico Medicine Hong Kong Limited. The trial plans to enroll 40 participants.