A phase III open-label extension study to evaluate long-term safety and efficacy of PRM-151 in patients with Idiopathic Pulmonary Fibrosis (IPF)

Phase 3

Completed

• Conditions: cryptogenic fibrosing alveolitis; idiopathic diffuse interstitial pulmonary fibrosis; 10037454

• Registration Number: NL-OMON52289
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Patients must meet the following criteria for study entry:
* Signed Informed Consent Form
* In the opinion of the Principle Investigator, participation in the study is
in the best
interest of the patient
* Ability to comply with the requirements of the study protocol, according to
the
investigator*s best judgment
* Taken part in a previous study of PRM-151, as follows:
o Participated in Study PRM-151-202 (completed the 28-week
placebo-controlled period and entered the OLE), and tolerated the study
drug in the opinion of the investigator (Cohort A) OR
o Completed study treatment in Study WA42293 (Cohort B) OR
o Participated in Study WA42293 but have discontinued from
study treatment (Cohort C; patients who completed treatment in
Study WA42293, but no longer wish to take PRM-151 may also join
Cohort C)
* For women of childbearing potential: agreement to remain abstinent (refrain
from
heterosexual intercourse) or use contraception, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate of
*1% per year during the treatment period and for 8 weeks after the final dose of
PRM-151.
A woman is considered to be of childbearing potential if she is postmenarchal,
has
not reached a postmenopausal state (*12 continuous months of amenorrhea with
no identified cause other than menopause), and is not permanently infertile due
to
surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another
cause as
determined by the investigator (e.g., Müllerian agenesis). The definition of
childbearing potential may be adapted for alignment with local guidelines or
regulations.
Examples of contraceptive methods with a failure rate of *1% per year include
bilateral tubal ligation, male sterilization, hormonal contraceptives that
inhibit
ovulation, hormone-releasing intrauterine devices, and copper intrauterine
devices.
Hormonal contraceptive methods must be supplemented by a barrier method.
The reliability of sexual abstinence should be evaluated in relation to the
duration of
the clinical trial and the preferred and usual lifestyle of the patient.
Periodic
abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods)
and
withdrawal are not adequate methods of contraception. If required per local
guidelines or regulations, locally recognized adequate methods of contraception
and
information about the reliability of abstinence will be described in the local
Informed
Consent Form.
* For men: agreement to remain abstinent (refrain from heterosexual
intercourse) or
use a condom, and agreement to refrain from donating sperm, as defined below:
With a female partner of childbearing potential or pregnant female partner, men
must remain abstinent or use a condom during the treatment period and for 8
weeks
after the final dose of PRM-151 to avoid exposing the embryo. Men must refrain
from donating sperm during this same period.
The reliability of sexual abstinence should be evaluated in relation to the
duration of
the clinical trial and the preferred and usual lifestyle of the patient.
Periodic
abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods)
and
withdrawal are not adequate methods of preventing drug exposure. If required per
local guidelines or regulations, inf

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study
entry:
* Received any experimental treatment other than PRM-151 within 4 weeks or
five half-lives of the experimental drug, whichever is longer, prior to the
first dose in
the OLE study
* Receiving strong inhibitor or inducer of CYP1A2 in patients taking pirfenidone
* Receiving potent inhibitor or inducer of P-gp in patients taking nintedanib
* 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 (including cigarette, cannabis, cigar, pipe, and vaping)
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 patient.
* 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, serum
chemistry, and urinalysis) that, in the opinion of the investigator, may
pose an additional risk in administering study drug to the patient.
* Any of the following laboratory abnormalities known at the time of the first
visit
- ALT and/or AST *2.5*upper limit of normal (ULN)
- Total bilirubin *2*ULN
* Pregnant or breastfeeding, or intending to become pregnant during the study
(for Cohort A or B patients)

Study & Design

• Study Type: Interventional
• Study Design: Not specified