The current study is a confirmatory, randomized, double-blind, placebo-controlled, Phase III clinical trial to assess the efficacy and safety of PRM-151 in patients with IPF with or without concurrent treatment with pirfenidone or nintedanib.
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy objective is to demonstrate superiority of 10 mg/kg
PRM-151 plus standard of care treatment as needed (excluding lung
transplantation) administered Q4W via IV infusion, over matching placebo plus
standard of care treatment as needed (excluding lung transplantation), on lung
function on the basis of absolute change in baseline to week 52 in forced vital
capacity (FVC (mL))
Secondary outcome
The secondary efficacy objective is to demonstrate superiority of 10 mg/kg
PRM-151
plus standard of care treatment as needed (excluding lung transplantation)
administered
Q4W via IV infusion, over matching placebo plus standard of care treatment as
needed
(excluding lung transplantation) on the basis of the following endpoints:
* Absolute change from baseline to Week 52 in 6MWD (in meters)
* Absolute change from baseline to Week 52 in FVC% predicted
* Time to disease progression, defined as time to first occurrence of >= 10%
absolute
decline in % predicted FVC, >= 15% relative decline in 6MWD, or death
* Time to first respiratory-related hospitalizations (defined as non-elective
hospitalizations due to any respiratory cause, including acute exacerbations of
IPF,
or suspected acute exacerbations of IPF, as determined by the clinical
Adjudication Committee)
* Change from baseline to Week 52 in University of California, San
Diego*Shortness
of Breath Questionnaire (UCSD-SOBQ)
* Change from baseline to Week 52 in St. George Respiratory Questionnaire (SGRQ)
Total Score
* Time to first acute exacerbation of IPF, or suspected acute exacerbation of
IPF, as
determined by clinical Adjudication Committee
* Change from baseline to Week 52 in carbon monoxide diffusing capacity (DLCO)
* Survival, as measured by all-cause mortality
The exploratory efficacy objective for this study is to evaluate the efficacy
of PRM-151
plus standard of care treatment as needed (excluding lung transplantation)
compared
with matching placebo plus standard of care treatment as needed (excluding lung
transplantation) on the basis of the following endpoints:
* Change from baseline to Week 52 in FVC% predicted, FVC (mL), by concurrent
therapy stratum (i.e., with nintedanib treatment vs. with pirfenidone treatment
vs.
without pirfenidone or nintedanib treatment)
* Change from baseline to Week 52 in FVC% predicted, FVC (mL), by MUC5B risk
allele positive or negative status
* Change from baseline to Week 52 in 6MWD, by concurrent therapy stratum
(i.e., with nintedanib treatment vs. with pirfenidone treatment vs. without
pirfenidone
or nintedanib treatment)
* Change from baseline to Week 52 in SGRQ Individual Domains (Symptoms,
Activity,
and Impacts) Score
* Change from baseline to Week 52 in the 6-minute walk test (6MWT) pre-test to
pre-test measurements of Borg dyspnea score, fatigue score, and oxygen
saturation
* Change from baseline to Week 52 in the 6MWT pre-test to post-test measurements
of Borg dyspnea score, fatigue score, and oxygen saturation
* Change from baseline to Week 52 in the 6MWT post-test to post-test
measurements
of Borg dyspnea score, fatigue score, and oxygen saturation
* Change from baseline to Week 52 in quantitative imaging analysis parameters of
HRCT scan of the thorax
* Length of hospital stay for respiratory-related hospitalizations, total time
in intensive
care units due to respiratory causes, deaths due to respiratory causes, and
unscheduled outpatient clinic/urgent care/emergency room utilization related to
respiratory events
* A decline or an increase in FVC% predicted of * 5%, * 10%, and * 15% from
baseline to Week 52
* A decline or an increase in FVC in mL of * 100 mL and * 200 mL from baseline
to
Week 52
* A decline or an increase in 6MWD * 5%, * 10%, * 15%, and * 20% from baseline
to
Week 52
* A decline or an increase in 6MWD * 25 m, and 50 m from baseline to Week 52
* Number of acute exacerbations during the 52 weeks
* At least one acute exacerbation during the 52 weeks; as determined by the
clinical Adjudication
Committee
* Survival as measured by IPF-related mortality
* Survival as measured by respiratory-related mortality
* Disease progression defined as: * 10% absolute decline in % predicted FVC;
respiratory hospitalization; or a decline of 50 m in 6MWD
* Disease progression and subsequently start pirfenidone or nintedanib or
switch from
nintedanib to pirfenidone (or vice versa)
* Time to worsening on the UCSD-SOBQ, as indicated by a change in score of
10 points or greater
* Time to worsening on the SGRQ total score, as indicated by a change in score
of
7 or greater
* Time to worsening on the SGRQ Activity domain, as indicated by a change in
score
of 5 or greater
* Time to worsening on the SGRQ Symptom Domain, as indicated by a change in
score of 8 or greater
* Time to worsening on the SGRQ Impact Domain, as indicated by a change in score
of 7 or greater
* Change in PFT parameters (FVC, 6MWT, or DLCO) from baseline to Week 52
between SARS-CoV2 antibody positive compared with negative patients
* Change in PFT parameters (FVC, 6MWT, or DLCO) from baseline to Week 52 in
patients who develop SARS-CoV2 antibodies during treatment (not present at
baseline)
Efficacy evaluations will be performed for the primary, secondary, and
exploratory
efficacy endpoints as detailed in Section 6.5. Exploratory analyses may also be
performed for additional measures and subgroups of interest. Details of all such
analyses will be provided in the Statistical Analysis Plan (SAP).
The safety objective for this study is to confirm the safety and tolerability
of 10 mg/kg of
PRM-151 administered Q4W via IV infusion plus standard of care treatment as
needed
relative to matching placebo plus standard of care treatment as needed in a
population
of all dosed patients, on the basis of the following endpoints:
* Incidence and severity of adverse events, with severity determined according
to the
5-point severity scale (National Cancer Institute Common Terminology Criteria
for
Adverse Events, Version 5.0 [NCI CTCAE, v.5.0])
* Incidence and severity of IRRs and other adverse events of special interest
* Proportion of patients permanently discontinuing study treatment due to
adverse events
* Change from baseline in targeted clinical laboratory test results
Safety analyses may also be performed for subgroups of interest. Details of
such analyses will be provided in the SAP.
The pharmacokinetic (PK) objective for this study is to characterize
pharmacokinetics of
PRM-151 in patients with IPF on the basis of the following:
* Serum concentrations of PRM-151 at specified timepoints
The exploratory PK objectives are to evaluate the potential relationship
between drug
exposure and the efficacy and safety of PRM-151 on the basis of the following:
* Relationship between PK for PRM-151 and efficacy endpoints
* Relationship between PK for PRM-151 and safety endpoints
The immunogenicity objective for this study is to evaluate the immune response
to
PRM-151 on the basis of the following:
* Prevalence of ADAs at baseline and incidence of ADAs during the study
The exploratory immunogenicity objective for this study is to evaluate
potential effects of
ADAs on the basis of the following:
* Relationship between ADA status and efficacy, safety, or PK endpoints
The exploratory biomarker objective for this study is to identify and/or
evaluate
biomarkers that are predictive of response to PRM-151 (i.e., predictive
biomarkers), are
early surrogates of efficacy, are associated with progression to a more severe
disease
state (i.e., prognostic biomarkers), are associated with acquired resistance to
PRM-151,
are associated with susceptibility to developing adverse events or can lead to
improved
adverse event monitoring or investigation (i.e., safety biomarkers), can
provide evidence
of PRM-151 activity (i.e., pharmacodynamic [PD] biomarkers), or can increase the
knowledge and understanding of disease biology and drug safety, on the basis of
the following:
* Relationship between biomarkers in blood listed in Section 4.5.12 and
efficacy,
safety, PK, immunogenicity, or other biomarker endpoints
The exploratory health status utility objective for this study is to evaluate
health status
utility scores of patients treated with PRM-151 plus standard of care treatment
as
needed on the basis of the following endpoint:
* Change from baseline to Week 52 in EuroQol 5-Dimension, 5-Level Questionnaire
(EQ-5D-5L) index-based, and visual analog scale (VAS) scores
Background summary
Idiopathic pulmonary fibrosis is a specific form of a chronic-fibrosing
interstitial pneumonia limited to the lung. It is a progressive inflammatory
lung disease that leads to significant morbidity and mortality. Pentraxin-2
(PTX-2) is a highly conserved endogenous serum protein and a soluble pattern
recognition receptor (PRR) of the innate immune system that regulates monocyte
activation and differentiation. PRM-151 is a recombinant human pentraxin-2
(rhPTX-2) protein. Of importance, patients with IPF (in comparison to healthy
subjects) have both increased fibrocyte numbers in circulation and decreased
levels of circulating PTX-2.
Supplementing endogenous PTX-2 levels through intravenous administration of
PRM-151 should theoretically increase the regulatory capacity of PTX-2 in
circulation and at the site of disease, thereby promoting healing and reducing
fibrosis.
Robust nonclinical and clinical data exist to support the investigation of
PRM-151 in the treatment of fibrotic diseases. Efficacy and safety of PRM-151
is also being investigated in patients with myelofibrosis in a Phase II study.
(see Protocol, 1. Background)
Study objective
The current study is a confirmatory, randomized, double-blind,
placebo-controlled, Phase III clinical trial to assess the efficacy and safety
of PRM-151 in patients with IPF with or without concurrent treatment with
pirfenidone or nintedanib.
Study design
This Phase III, randomized, double-blind, placebo-controlled, pivotal study is
designed to confirm the efficacy and safety of PRM-151 in the treatment of
patients with IPF during a 52-week period. At the end of this 52-week period,
patients will be invited to enroll in an open-label extension (OLE) study
(Study WA42294) to receive treatment with PRM-151. Patients who do not enroll
in the OLE study will be followed up for an additional 4 weeks (to Week 56, for
safety monitoring). The OLE study will provide patients with further study
assessments and PRM-151 treatment
on an ongoing basis. However, the OLE study will also consist of a long-term
survival cohort, where patients who do not want further study assessments or
treatment can enroll (for longterm collection of survival data only). Patients
meeting the eligibility criteria for the study will be randomized to PRM-151 10
mg/kg Q4W or placebo. Efficacy will be evaluated through assessment of
functional capacity as measured by FVC, 6MWD, other pulmonary function tests
(PFTs), and assessment of patients with respiratory events leading to
hospitalizations, progression of disease, acute IPF exacerbations.
Patient reported outcomes (PROs) will be assessed using the SGRQ, UCSD-SOBQ,
and EQ-5D-5L. Dyspnea, fatigue, and SpO2 will be assessed based on measurements
taken during the 6MWT. For patients who require a HRCT scan during the
screening period, an additional chest HRCT
scan will be performed at Week 52. Patients who do not require a HRCT scan
during the screening period (i.e., they already have a historic HRCT scan of
acceptable quality performed within 12 months prior to screening) will not be
required to perform a scan at Week 52.Treated patients will be followed until
the end of the 52-week study period unless the patient withdraws consent for
follow-up or dies. Patients will be evaluated for study eligibility during a
screening period of up to 4 weeks. If any patient is prevented from completing
required screening procedures within the 4-week period due to unforeseeable
circumstances. Screening can be extended up to a maximum of 2 weeks. Patients
who are determined to be eligible based on the screening assessments will
be randomized into the study and randomly allocated to treatment with PRM-151
or placebo. Patients entering the screening period on anti-fibrotic therapy
(pirfenidone or nintedanib) should have been on treatment for at least 3
months, and on a stable dose for at least 4 weeks prior to
the screening visit and are expected to remain on their specific dose and
regimen throughout the study duration unless dose reduction or discontinuation
is indicated for safety or tolerability reasons.
Patients entering the screening period of the study NOT on anti-fibrotic
treatment (pirfenidone or nintedanib), either treatment naive or having
previously taken and discontinued, must have been off such treatment for at
least 4 weeks prior to the screening visit and during screening.
At the time of consent, if a patient is considering starting treatment with
either nintedanib or pirfenidone, the patient should be advised of being on
treatment for at least 3 months prior to screening.
For all patients receiving anti-fibrotic therapy, the investigator should
document the dose, frequency, and duration of the anti-fibrotic drug. For
patients not receiving anti-fibrotic therapy during the screening period, the
investigator should document the reason(s). During the study, patients may
initiate pirfenidone or nintedanib as rescue, if determined to be clinically
indicated by the investigator. The investigator may consider discussing changes
in anti-fibrotic therapy with the Medical Monitor throughout the study. The
investigator is required to document the specific reason for introducing
anti-fibrotic therapy in patients who were randomized into the study not on
anti-fibrotic therapy.
Approximately 658 patients will be randomly assigned on a 1:1 basis to
treatment with PRM-151 or placebo, as follows:
* PRM-151 Group: PRM-151 10 mg/kg IV infusion over 50-70 minutes on Days 1, 3,
and 5, then one infusion Q4W for 48 weeks
* Placebo Group: Matched placebo IV infusion over 50-70 minutes on Days 1, 3,
and 5, then one infusion Q4W for 48 weeks
The randomization will be stratified as follows:
* Concurrent use of nintedanib treatment versus pirfenidone treatment versus no
concurrent treatment
* Region: China (including Hong Kong and Taiwan), North America (United States
and Canada), Europe (including eastern Europe), Latin America, and Rest of
World (including east Asia, Australia, and New Zealand)
All patients will have a final assessment visit at Week 52 (4 weeks after the
final study drug infusion). Patients will be invited to enroll in an OLE study
at this point (Study WA42294), and if they roll over into that study, the Week
52 visit will be considered their end of study visit. Patients who do not
enroll in the OLE study will have their end of study visit at Week 56, in
addition to the Week 52 visit.
Intervention
Patients randomized to study drug will receive IV infusions of 10 mg/kg PRM-151
over approximately 50 to 70 minutes, with dose based on the patient*s weight
taken at the same clinic visit (for loading or reloading doses, the weight
taken at the first clinic visit for the first dose can be applied to the second
and third doses).
Patients randomized to placebo will receive IV infusions of placebo over
approximately 50-70 minutes.
Study burden and risks
PRM-151, a recombinant form of an endogenous human protein, was generally well
tolerated in nonclinical toxicity studies and in Phase I and II clinical
studies. Clinically and statistically significant positive effects with PRM-151
were observed in the Phase II IPF study, both for change in FVC (% predicted)
and 6MWD through 28 weeks of treatment. Based on encouraging Phase I and II
data in subjects with IPF, PRM-151 has the potential to be a well-tolerated,
disease modifying treatment for a broad spectrum of fibrotic diseases,
including IPF.
In the two Phase I studies of PRM-151 administered intravenously to normal
volunteers and patients with IPF, no serious adverse events were reported and
no other safety signals were seen. The single ascending dose study
(PRM151A-11EU) tested dose levels as high as 20 mg/kg. The multiple ascending
dose study (PRM151F-12GL) demonstrated that PRM-151 administered by 30-minute
IV infusion on Days 1, 3, 5, 8, and 15 at up to 10 mg/kg was safe and well
tolerated in subjects with IPF, with no serious adverse events noted in 57
days. In the Phase II study, PRM-151 was generally well tolerated through at
least 6 months of treatment.
Risks associated with PRM-151 are inherent in it being the recombinant form of
a naturally occurring human protein and consist of potential development of ADA
and infusion reactions. PRM-151 has an endogenous counterpart; therefore, ADAs
could develop that could potentially affect the efficacy of PRM-151 treatments
in addition to having the potential to cross-react with endogenous hPTX-2.
PRM-151 is not a general immunosuppressant, and treatment with PRM-151 is not
expected to increase rates of infection or adversely affect wound healing.
As with any protein therapeutic, the potential for reactions exists and safety
procedures will be implemented, including careful monitoring of patients during
infusions and of infusion sites. Appropriate personnel, medication, and other
requirements for the treatment of potential infusion reactions will be required
by the protocol. PRM-151 is an investigational agent and the potential benefits
of PRM-151 as a therapy for IPF remain to be proven in clinical efficacy
studies. (See Protocol, 1.3.1)
Grenzacherstrasse 124
Basel 4070
CH
Grenzacherstrasse 124
Basel 4070
CH
Listed location countries
Age
Inclusion criteria
* Signed Informed Consent Form
* Age 40-85 years, inclusive, at time of signing Informed Consent Form
* Ability to comply with the requirements of the study protocol, according to
the investigator*s
best judgment
* Documented diagnosis of IPF per the 2018 ATS/ERS/JRS/ALAT Clinical Practice
Guideline
* HRCT pattern consistent with the diagnosis of IPF, confirmed by central
review of Chest
HRCT (available HRCT of acceptable quality performed within 12 months prior to
screening
or obtained during the screening period) and central review of any available
lung biopsy (LB)
* Minimum 6MWD of 150 meters with maximum use of 6 L/min at sea-level and up-to
8 L/min
at altitude (* 5000 feet [1524 meters] above sea level) of supplemental oxygen
while
maintaining oxygen saturation of * 83% during the 6MWT during screening
* FVC * 45% predicted during screening as determined by the over-reader
* Forced expiratory volume in 1 second (FEV1)/FVC ratio * 0.70 during screening
as determined by the over-reader
* DLCO * 30% and * 90% of predicted during screening (Hgb corrected or
uncorrected) as determined by the over-reader
* If receiving pirfenidone or nintedanib treatment for IPF, the patient must
have been on
treatment for at least 3 months and on a stable dose for at least 4 weeks prior
to screening,
and during screening (with no contraindications according to local prescribing
information)
* If not currently receiving nintedanib or pirfenidone treatment (either
treatment naïve or
having previously taken and discontinued) must have discontinued such treatment
* 4 weeks prior to screening and during screening
If patient is considering starting treatment with either nintedanib or
pirfenidone, patient
must be on treatment for at least 3 months prior to screening, provided there
are no
contraindications according to local prescribing information.
* For women of childbearing potential: (excluding patients enrolling in Japan):
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.
PRM-151*F. Hoffmann-La Roche Ltd
23/Protocol WA42293, Version 2 (VHP)
* 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, information about the reliability of abstinence will be described
in the local
Informed Consent Form.
* Anticipated life expectancy of at least 12 months at baseline, according to
the
investigator*s judgment
* Patient and investigator considered all medicinal treatment options and/or
possibly lung
transplantation prior to considering participation in the study. If the patient
is on a lung
transplant list, the investigator anticipates the patient will be able to
complete the study prior
to transplant.
* For patients enrolled in the extended China enrollment phase:
current resident of mainland China, Hong Kong, or Taiwan, and of Chinese
ancestry
Exclusion criteria
* Evidence of other known causes of interstitial lung disease (e.g., domestic
and occupational
environmental exposures, connective-tissue disease, and drug toxicity)
* FVC% predicted value showing improvement in the 6-month period prior to
screening and
including screening value, as assessed by the investigator
* Emphysema present on * 50% of the HRCT, or the extent of emphysema is greater
than the
extent of fibrosis, according to central review of the HRCT
* Receiving nintedanib in combination with pirfenidone
* Received cytotoxic, immunosuppressive, cytokine modulating, or receptor
antagonist
agents (including but not limited to methotrexate, azathioprine, mycophenolate
mofetil,
cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks
prior to or during screening
* Receiving systemic corticosteroids equivalent to prednisone * 10 mg/day or
equivalent
within 2 weeks prior to or during screening
* 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 either
during screening or
prior to screening and not successfully resolved 4 weeks prior to screening
visit
* Positive interferon gamma release assay
- Test for tuberculosis during screening: Patients who have completed treatment
for tuberculosis within 6 months prior to screening, and have no evidence of
recurrent disease, do not need to
be tested
* Resting oxygen saturation of * 89% using up to 4 L/min of supplemental oxygen
at sea
level and up-to 6 L/min at altitude (* 5000 feet [1524 meters] above sea level)
during
screening
* Co-existing acute or chronic medical condition that, in the investigator*s
opinion, would
substantially limit the ability to comply with study requirements or may
influence any of the
safety or efficacy assessments included in the study
* Class IV New York Heart Association chronic heart failure
PRM-151*F. Hoffmann-La Roche Ltd
24/Protocol WA42293, Version 2 (VHP)
* Historical evidence of left ventricular ejection fraction * 35%
* Presence of pulmonary hypertension that, in the investigator*s opinion, would
substantially limit the ability to comply with study requirements or may
influence any of
the safety or efficacy assessments included in the study
* Cardiopulmonary rehabilitation program based on exercise training that has
been
completed within 8 weeks prior to screening or planned to start during the
patient*s
enrollment in this trial
* History of smoking (including cigarette, cannabis, cigar, pipe and vaping)
within 3 months
prior to or during screening
* History of alcohol or substance use disorder within 2 years prior to or
during screening or known or
suspected active alcohol or substance-use disorder
* History of a malignancy within the 5 years prior to screening, with the
exception of basal cell
or squamous cell skin neoplasms. In addition, a malignant diagnosis or
condition that
occurred more than 5 years prior to screening, and any basal cell or squamous
cell
neoplasm must be considered cured, inactive, and not under treatment.
* Unable to refrain from use of the following:
- Short acting bronchodilators (SABA) within 4 hours before pulmonary function,
DLCO, and
6MWT assessments
- Once daily, long-acting bronchodilators within 24 hours before pulmonary
function, DLCO,
and 6MWT assessments
- Twice daily, long-acting bronchodilators within 12 hours before pulmonary
function testing,
DLCO, and 6MWT assessments
* Known post-bronchodilator response in FEV1 and/or FVC * 12% and * 200 mL,
respectively
* Receipt of an investigational drug within 4 weeks, or 5 half-lives, whichever
is longer, prior
to or during screening
* Previous treatment with PRM-151
* History of severe allergic reaction or anaphylactic reaction to a biologic
agent including any allergies to the additives of the drug product.
* Clinically significant abnormality on ECG during screening 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) on
ECG during screening, based on the Fridericia correction formula
* Clinically significant laboratory test abnormalities during screening
(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 during screening:
- ALT and/or AST * 2.5 * upper limit of normal (ULN)
- Total bilirubin * 2 * ULN
* Pregnant or breastfeeding, or become pregnant during the study or within
8 weeks after the final dose of PRM-151
Women of childbearing potential must have a negative serum pregnancy test
result within
30 days prior to initiation of study drug.
* Women of childbearing potential (Only for patients enrolling in Japan)
- 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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-000791-38-NL |
| ClinicalTrials.gov | NCT04552899 |
| CCMO | NL75034.078.21 |