A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)

JRCT ID: jRCT2001210001

Registered date:26/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Idiopathic pulmonary fibrosis
• Date of first enrollment: 06/01/2022
• Target sample size: 60
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,South Korea,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Norway,Japan,Peru,Japan,Poland,Japan,Portugal,Japan,Russian Federation,Japan,Singapore,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan
• Study type: Interventional
• Intervention(s): Patients will receive IV infusions of 10 mg/kg PRM-151 over 50-70 minutes, with dose based on the patients weight recorded at each visit

Outcome(s)

Primary Outcome

1.Percentage of Participants with Adverse Events (AE)
2.Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest
3.Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs
4.Change from Baseline in Targeted Clinical Laboratory Test Results

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclude criteria

- Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
- History of smoking within 3 months prior to the first visit in the OLE.
- History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
- History of severe allergic reaction or anaphylactic reaction to PRM-151.
- Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
- Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula
- Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.

Related Information

• Primary Sponsor: Shimoda Yukiko
• Secondary ID(s): NCT04594707