This study has been transitioned to CTIS with ID 2023-508729-28-00 check the CTIS register for the current data. The purpose of the study is to look at how well the study treatment works in participants with idiopathic pulmonary fibrosis.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Change from baseline to end of treatment epoch (26 weeks of treatment) in
Forced Vital Capacity (FVC) expressed in percent predicted
Secondary outcome
• Change from baseline to end of treatment epoch (26 weeks of treatment) in
Forced Vital Capacity (FVC) expressed in mL
• Time to progression as defined by a composite endpoint including any of the
following events:
• Absolute reduction from baseline of >=10% predicted in FVC
• Nonelective hospitalization for respiratory events
• Lung Transplant
• Death
• Number of participants with absolute decline of >=10% predicted in FVC
• Change from baseline to the end of treatment epoch (26 weeks of treatment) in
DLCO absolute and percent predicted
• Change from baseline to the end of treatment epoch (26 weeks of treatment) in
6-minute walk distance
• Change from baseline to the end of treatment epoch (26 weeks of treatment) in
scores from the L-IPF (Impacts and Symptoms Modules), K-BILD, Leicester cough,
and R-Scale for PF questionnaires
• Adverse Events , physical examinations, labs, ECGs, vital signs
Background summary
Current drugs against IPF are able to slow the progression of the disease, but
they cannot stop it. Thus, there is a need for new agents to treat the disease.
In this study, the study medication (LTP001 or placebo) can usually be added to
your existing treatment for IPF. The researcher will discuss this with you.
LTP001 has not yet been approved (*registered*) as a medicine by the Dutch
government. Doctors should not prescribe the drug to patients. LTP001 can only
be administered during a medical scientific examination. For registration,
research in patients is required. That is why your cooperation in this research
is requested.
Up to October 2021, approximately 72 healthy subjects have been treated with
LTP001. But the drug has not yet been studied in patients with IPF. So we don't
know if the drug will work for you. Your health may improve, deteriorate or not
change during the examination.
Study objective
This study has been transitioned to CTIS with ID 2023-508729-28-00 check the CTIS register for the current data.
The purpose of the study is to look at how well the study treatment works in
participants with idiopathic pulmonary fibrosis.
Study design
We compare the effect of research medication with the effect of a placebo. This
study is designed as a platform study. The initial submission only includes
research medication LTP001. Other agents can be added through a protocol
amendment.
In this study, participants are treated for 26 weeks after which lung function
is compared with the start of the study.
Intervention
Treatment with LTP001 or placebo.
Study burden and risks
The following adverse reactions were reported by subjects taking LTP001: rash,
dizziness, and diarrhea (by 2 subjects). The following side effects were
reported by 1 subject each: joint pain, flu-like complaints, complaints *if you
are going to pass out*, problems with sleeping, muscle pain, being hyperalert,
abdominal pain, skin damage, increased testosterone and cortisol in the blood,
contact dermatitis (acute inflammation of the skin due to irritation or allergy
with, among other things, itching, redness), headache and blocked sinuses.
The examinations are also regularly applied during the usual medical treatment.
• Blood draw. Blood tests can hurt or cause bruising. Sometimes a person gets
dizzy or faints. An infection is rare. During this examination, a maximum of 50
ml of blood is taken at a time. In comparison: someone who gives blood to the
blood bank, gives 500 ml of blood at a time.
• Lung function examination. With a spirometry we measure how much air you
inhale and exhale and how easily and quickly you can exhale completely.
Spirometry is generally a safe procedure. You may experience a cough or
shortness of breath during or after this examination. Other potential risks of
spirometry include dizziness or headaches.
The lung diffusion test and the forced oscillation technique have no side
effects or risks.
• Lung scan (High Resolution CT, HRCT). A lung scan produces very sharp images
of the lungs and surrounding tissues of the chest. This is done at the
beginning and end of the treatment period. It is not a painful procedure. A few
minutes of the procedure can be a little uncomfortable. The researcher will
give you more information. If you have any questions, you can ask your
researcher or the department where the scan is made.
During a lung scan you are exposed to radiation. In this study, you will
receive a total of about 18 mSv (about 8.9 mSv at a time) of radiation. By way
of comparison: the 'normal' radiation that everyone in the Netherlands receives
anyway is approximately ~2.9 mSv per year. It does not hurt if you have to
undergo an examination or treatment with radiation for a medical reason.
o Do you receive radiation examinations more often? Then discuss with the
researcher whether it is wise for you to participate.
o The radiation we use during the research can damage your health. But this is
a small risk. We do, however, advise you not to participate again in scientific
research involving radiation in the near future.
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
-Male and female participants at least 40 years of age
-IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
-FVC >=45% predicted
-DLCO, corrected for hemoglobin, >=25% predicted (inclusive)
-Unlikely to undergo lung transplantation during this trial in the opinion of
the investigator
-If a participant is taking nintedanib or pirfenidone, they must be on a stable
regimen for at least 8 weeks prior to randomization
Additional protocol-defined inclusion criteria may apply.
Exclusion criteria
-Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening -Emphysema >20% on screening HRCT -Fibrosis <10% on screening HRCT -Clinical diagnosis of any connective tissue disease -Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization Additional protocol-defined exclusion criteria may apply.
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 |
|---|---|
| EU-CTR | CTIS2023-508729-28-00 |
| EudraCT | EUCTR2021-005066-17-NL |
| CCMO | NL81665.100.22 |