Induction PeriodPrimary:Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical remission.Secondary:* Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical response* Demonstrate the efficacy of RPC1063…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Complete Mayo score: the sum of the Rectal Bleeding subscore, Stool Frequency
subscore, Physician
Global Assessment subscore, and the Endoscopy subscore. Each subscore has a
range of 0-3 points and
the complete Mayo score has a range of 0-12 points
Partial Mayo score: the sum of the Rectal Bleeding subscore, Stool Frequency
subscore, and the
Physician Global Assessment subscore. The partial Mayo score has a range of 0-9
points
9-point Mayo score: the sum of the Rectal Bleeding subscore, Stool Frequency
subscore, and the
Endoscopy subscore. The 9-point Mayo score has a range of 0-9 points
Clinical Remission
Definition 1: Complete Mayo score of * 2 points with no individual subscore of
> 1 point
Definition 2: Rectal Bleeding subscore = 0 and Stool Frequency subscore * 1
(and a decrease of
* 1 point from the Baseline Stool Frequency subscore) and Endoscopy subscore * 1
Clinical Response
Definition 1: A reduction from Baseline in the Complete Mayo score of * 3
points and * 30%, and a
reduction from Baseline in the Rectal Bleeding subscore of * 1 point or an
absolute Rectal Bleeding
subscore of * 1 point
Definition 2: A reduction from Baseline in the 9-point Mayo score of * 2 points
and * 35%, and a
reduction from Baseline in the Rectal Bleeding subscore of * 1 point or an
absolute Rectal Bleeding
subscore of * 1 point
Durable Remission: Clinical remission at Week 10 and at 52 weeks in all
patients who entered the
Maintenance Period
Corticosteroid-free Remission: Clinical remission at 52 weeks while off
corticosteroids for *12 weeks
Endoscopic Improvement: Endoscopy subscore of * 1 point
Mucosal Healing: Endoscopy subscore of * 1 point and a Geboes index score < 3.0
Histologic Remission: Geboes index score < 3.0
Disease relapse: has occurred when all of the following criteria are met:
* An increase in UC disease activity as defined by an increase in partial Mayo
score of *2 points
compared to the Week 10 partial Mayo score with an absolute partial Mayo score
*4 points
* An endoscopic subscore of *2 points
* Exclusion of other causes of an increase in disease activity unrelated to
underlying UC
(e.g., infections, change in medication)
Induction Period, Cohort 1 (Efficacy of RPC1063 vs Placebo):
For statistical analysis purposes, clinical remission and clinical response
will be calculated using Definition
1 for all regulatory regions except the US FDA. For US regulatory purposes,
Definition 2 will be used to
calculate clinical remission and clinical response. All patients will
contribute to each calculation regardless
of enrollment region.
Primary Efficacy Endpoint:
* The proportion of patients in clinical remission at Week 10
Induction Period, Cohort 2
Cohort 2 is open label; therefore no formal analysis of efficacy endpoints will
be conducted. All efficacy
endpoints listed above will be summarized and described without hypothesis
testing.
Maintenance Period:
For statistical analysis purposes, clinical remission and clinical response
will be calculated using Definition
1 for all regulatory regions except the US FDA. For US regulatory purposes,
Definition 2 will be used to
calculate clinical remission and clinical response. All patients will
contribute to each calculation regardless
of enrollment region.
Primary Efficacy Endpoint:
* The proportion of patients in clinical remission at 52 weeks
Safety:
The incidence, severity, and relationship of treatment-emergent adverse events
(TEAEs), serious AEs
(SAEs), TEAEs leading to discontinuation of investigational drug, and TEAEs of
special interest. Clinically
meaningful changes from Baseline on clinical laboratory measures, vital signs,
ECGs, pulmonary function
tests, physical examinations, and optical coherence tomography.
Secondary outcome
Key Secondary Efficacy Endpoints:*
The proportion of patients with a clinical response at Week 10
* The proportion of patients with endoscopic improvement at Week 10
* The proportion of patients with mucosal healing at Week 10
Other Efficacy Endpoints:
* Change in Mayo score from Baseline to Week 10
* Proportion of patients with histologic remission at Week 10
* Proportion of patients with clinical response, remission, or endoscopic
improvement at Week 10
in patients who previously received anti-TNF therapy
* Change in the SF-36 and the EQ-5D from baseline to Week 10
* Health resource utilization at Week 10
* Work productivity at Week 10
Key Secondary Efficacy Endpoints:
* The proportion of patients with a clinical response at 52 weeks
* The proportion of patients with endoscopic improvement at 52 weeks
* The proportion of patients with durable clinical remission
* The proportion of patients in clinical remission at 52 weeks in the subset of
patients who were
in remission at Week 10
* The proportion of patients with corticosteroid-free remission
* The proportion of patients with mucosal healing at 52 weeks
Other Efficacy Endpoints:
* Change in Mayo score from Maintenance Baseline (just prior to entry into the
Maintenance Period)
to 52 weeks
* The proportion of patients with histologic remission at 52 weeks
* The proportion of patients with clinical response, remission, or endoscopic
improvement at
52 weeks in patients who previously received anti-TNF therapy
* The proportion of patients in remission at 52 weeks while off corticosteroids
for any length of time
* Change in the SF-36 and the EQ-5D from Maintenance Baseline (just prior to
entry into the
Maintenance Period) to 52 weeks
* Health resource utilization at Weeks 30 and 42, and at 52 weeks
* Work productivity at Week 30 and at 52 weeks
Background summary
RPC1063 is a small molecule compound that potently activates the sphingosine-1-
phosphate 1 receptor (S1P1R) and the S1P 5 receptor (S1P5R) receptor, although
it is more
selective towards S1P1R over S1P5R. In vitro, RPC1063 has little activity on
the other
sphingosine-1-phosphate (S1P) receptors, showing greater than 20,000-fold
selectivity over
S1P 2R, 3R, or 4R. The RPC1063 metabolites, RP101075 and RP101442, show a
similar
potency and selectivity profile to RPC1063. RPC1063 and metabolites were also
shown to
be selective for binding to the S1P1R and S1P5R relative to a G protein-coupled
receptors
enriched panel of 55 non-target receptors in vitro.
RPC1063 has been studied in two Phase 1 studies completed (RPCS-001 and
RPC01-102) in
healthy volunteers, the latter was a thorough QT study that showed RPC1063 at
therapeutic
(1 mg) and supratherapeutic (2 mg) doses did not prolong the QTc interval.
A Phase 2/3 randomized, double-blind, controlled trial (RPC01-201, RADIANCE) in
patients with relapsing multiple sclerosis (RMS) is ongoing, with positive
efficacy and safety
results reported from the 24-week, Phase 2 portion of the trial in June 2014.
The Phase 3
portion of the trial is still enrolling and expected to complete in 2017. The
induction phase of
a Phase 2 trial in adult patients with moderate to severe UC (RPC01-202) was
completed in
October 2014. At the conclusion of the induction phase, the proportion of
patients achieving
clinical response and clinical remission with RPC1063 1 mg was greater than
placebo and
the difference was both clinically meaningful and statistically significant. In
addition, all
secondary endpoints at the conclusion of the induction phase, including
clinical response,
change in the Mayo score, and mucosal improvement on endoscopy, were also
positive and
statistically significant for the RPC1063 1 mg dose. The maintenance phase of
this trial is
expected to be completed in 2015.
Study objective
Induction Period
Primary:
Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical
remission.
Secondary:
* Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical
response
* Demonstrate the efficacy of RPC1063 versus placebo on achieving endoscopic
improvement
* Demonstrate the efficacy of RPC1063 versus placebo on achieving histologic
remission
* Demonstrate the safety and tolerability of RPC1063 induction therapy
Maintenance Period
Primary:
To demonstrate the efficacy of RPC1063 versus placebo maintenance therapy on
clinical remission.
Secondary:
* Demonstrate the efficacy of RPC1063 versus placebo in maintaining clinical
response
* Demonstrate the efficacy of RPC1063 versus placebo on achieving endoscopic
improvement
* Demonstrate the efficacy of RPC1063 versus placebo on durability of clinical
remission
* Demonstrate the efficacy of RPC1063 versus placebo on maintaining clinical
remission among
patients who achieved remission during induction therapy
* Demonstrate the efficacy of RPC1063 versus placebo, in achieving
corticosteroid-free remission
among patients receiving corticosteroids at entry into the Maintenance Period
* Demonstrate the safety and tolerability of RPC1063 maintenance therapy
Study design
Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Induction Period:
Cohort 1: On Induction Day 1, patients will be randomly assigned in a 2:1 ratio
to:
RPC1063: Taken by mouth, starting with a 7-day dose titration regimen of
RPC1063 at 0.25 mg/day on
Days 1 to 4 and RPC1063 at 0.5 mg/day on Days 5 to 7, followed by 1 mg once
daily (a single 1.0 mg
capsule starting Day 8) x 9 weeks, or
Matching placebo: Taken by mouth once daily x 10 weeks with matching dose
titration Days 1 to 7
Cohort 2: All patients take RPC1063 by mouth, starting with a 7-day dose
titration regimen of RPC1063
at 0.25 mg/day on Days 1 to 4 and RPC1063 at 0.5 mg/day on Days 5 to 7,
followed by 1 mg once daily
(a single 1.0 mg capsule starting Day 8) x 9 weeks.
Maintenance Period:
On Maintenance Day 1, patients with clinical response to RPC1063 during the
Induction Period will be
randomly assigned in a 1:1 ratio to:
RPC1063 taken by mouth (a single 1.0 mg capsule) once daily × 42 weeks, or
Matching placebo taken by mouth (a single capsule) once daily × 42 weeks
Patients with a response to placebo during the Induction Period will continue
to receive placebo taken by
mouth once daily x 42 weeks. Patients who have disease relapse during the
Maintenance Period will be
given the option to enroll in an open-label extension trial.
Intervention
The trial is composed of 2 periods: Induction and Maintenance. Patients will be
entered into the trial in
2 separate cohorts through the Induction Period and those patients in clinical
response at the end of the
Induction Period will proceed through to the Maintenance Period. Patients who
participate in this trial may
also qualify to participate in an optional Open-Label Extension trial.
Induction Period:
The 10-week Induction Period is composed of 2 cohorts:
* Cohort 1: Approximately 495 patients will be randomized in a 2:1 ratio to
receive either RPC1063
1 mg or placebo once daily in a double-blind fashion, stratified by
corticosteroid use at screening
(yes or no) and prior anti-TNF use (yes or no)
* Cohort 2: Approximately 405 patients will receive open-label RPC1063 1 mg
once daily
Patient eligibility for the Induction Period will be determined during a 5-week
Screening Period.
The trial will include both patients that have received anti-TNF therapy and
those that have not. The
proportion of patients who have previously received anti-TNF therapy will be
limited to *30% in Cohort 1.
All patients will initiate investigational drug via a 7-day dose titration
regimen starting with RPC1063
0.25 mg or matching placebo (matching placebo for Cohort 1 only) on Days 1 to 4
and RPC1063 0.5 mg
once daily or matching placebo on Days 5 to 7. On Day 8, patients will receive
the final dose level
(1 mg once daily or matching placebo) for 9 weeks.
Patients from either Cohort who are determined to be in clinical response at
the end of the Induction Period
(Week 10) may enter the Maintenance Period, while patients not showing a
clinical response may enter an
optional Open-Label Extension trial.
Maintenance Period:
It is anticipated that at least 400 patients who complete the Induction Period
(both Cohort 1 and Cohort 2)
will be in clinical response at Week 10 and will be eligible to enter the
randomized, double-blind, placebocontrolled
Maintenance Period. Patients in clinical response at Week 10 of the Induction
Period who
received RPC1063 during Induction will be randomized to receive either RPC1063
1 mg or matching
placebo in a 1:1 ratio. Patients in clinical response at Week 10 of the
Induction Period who were randomized
to placebo (Cohort 1) will continue to receive placebo in the Maintenance
Period in a double-blind manner.
The randomization in the Maintenance Period will be stratified by clinical
remission status at Week 10
(yes or no) and corticosteroids use at Week 10 (yes or no). Patients will be
evaluated for disease
activity/efficacy at Week 42 of the Maintenance Period (52 weeks of treatment).
Optional Open-Label Extension Trial:
Patients who complete the Induction Period and are non-responders at Week 10,
and those that complete the
Maintenance Period or experience disease relapse during the Maintenance Period,
will have the option to
enter a separate Open-Label Extension trial (submitted under NL54683.029.15).
Study burden and risks
The following side effects were considered as related, probably related or
possibly related to the study drug. All of these events were mild or moderate
in severity. No severe side effects occurred.
Common (frequent) seen in both patients with UC and Multiple Sclerosis (MS)*
expected to occur in at least 1 of 100 persons but less than 10 of 100 persons
(* 1% to < 10%):
* Increased level of alanine aminotransferase (a liver enzyme that might
suggest the existence of other medical problems): 6 patients
* Increased level of aspartate aminotransferase (also a liver enzyme that might
suggest the existence of other medical problems): 4 patients
* Orthostatic hypotension (low blood pressure): 4 patients
* Insomnia (trouble to fall asleep and/or staying asleep): 4 patients
Uncommon (infrequent) * expected to occur in at least 1 of 1000 persons but
less than 10 of 1000 persons (* 0.1% to < 1%):
* Weight loss: 2 patients
* Vitreous detachment (The jelly in the eye peels away from the retina.
Symptoms may include sudden onset of floaters (an impression like flying
insects), bright flashes of light, and blurred vision): 2 patients
* Nausea (feeling sick): 2 patients
* Back pain: 2 patients
* Asthma (sore and swollen, sensitive airways): 2 patients
* Increased gamma-glutamyltransferase (an enzyme that may indicate malfunction
of the liver and bile): 2 patients
In addition, macular degeneration, which is often diagnosed in patients with MS
as part of their disease, has been seen only in MS (3 patients). Macular
degeneration, when severe, can decrease your ability to see objects clearly.
There were no severe cases reported among these patients.
As for all new drugs, there may also be side effects and discomforts that are
not yet known, which include UC getting worse or even death.
Side effects of procedures and assessments
The following side effects of the procedures/assessments might occur during
participation in the study:
Blood draw: During this study, blood will be taken to perform a variety of
tests. This may cause discomfort, pain, bruising, swelling, blood clot
formation, and very rarely infection at the site where the skin is punctured by
the needle. Patients may also experience dizziness, nausea or fainting during
the blood draw.
To reduce the number of punctures of blood vessels, a catheter may be inserted
into the vein of the arm of the patient and will remain in place until after
completion of the pharmacokinetic sample collection. If a catheter is used, it
may cause discomfort, redness or bruising around the insertion site. In rare
cases, the insertion site may become infected.
Tuberculosis skin test: The test may cause mild itching or discomfort at the
injection site.
Electrocardiogram (ECG): The patches that the study staff will stick to the
chest and other areas of the body to monitor the heart may irritate the skin
and cause itching and redness. The study staff might need to shave body hair
so that they can stick the pads to the skin. The shaving may cause some
irritation (depending on the tools and soap used); also, a local allergic
reaction could occur. When the sticky patches are removed, it might sting for a
few seconds. The test itself is painless.
Pulmonary Function Tests: This could possibly make the patient feel
lightheaded. After the first test, a medicine used to open the small airways in
the lungs (bronchodilator) will be used and the test repeated to check for any
changes. Side effects are rare and short-lived and may include cough, trembling
and fast heartbeat.
Optical coherence tomography (OCT): During the OCT examination, patients might
experience some discomfort related to dilated pupils.
Colonoscopy or sigmoidoscopy with colonic biopsy: The study doctor or study
staff will perform a procedure to look inside the colon to take a sample of the
colon tissue. In rare cases this will result in problems, such as bleeding.
Side effects from the sedation or anesthesia given for the procedure may also
occur.
Chest X-ray: The chest x-ray at screening exposes the body to radiation;
Risk of receiving placebo instead of active drug during the study: Some people
in the study will get placebo instead of the study drug. Taking placebo is the
same as not taking anything for UC and the UC may get worse.
There is a risk of loss of confidentiality of the personal information that is
used in this study. However, the data collected cannot be traced back to the
patient.
Harm to the unborn child
For women:
Currently we are not fully aware of the effects of the study drug on unborn
babies, or pregnant or breastfeeding women. If the patient is pregnant, or may
become pregnant, treatment with the study drug may lead to new, previously
unknown, side effects that we currently do not know about and this may involve
risks to the patient or the unborn baby. Because of this, women who are not
surgically sterilized and can have children will be asked to take a pregnancy
test at the start of the study and at each study visit. the patient must be
using an effective form of birth control before they start the study drug and
while taking part in the study.
Any treatment with a new substance may lead to the occurrence of new,
previously unknown side effects/adverse events, which are currently
unforeseeable.
We do not know if the study drug will affect sperm or semen so patients should
not father a child during this study or for 30 days after treatment. If the
patient is not vasectomized and the partner might become pregnant, the patient
must use effective, reliable forms of birth control during the study and for 30
days afterwards.
Positive Phase 2 results on remission rates during the Induction Period of
protocol RPC01-202 suggest that RPC1063 has the potential to be a
clinically-meaningful addition to the therapeutic armamentarium for the
treatment of moderate to severe UC.
Rue du Pre-Jorat 14
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CH
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CH
Listed location countries
Age
Inclusion criteria
1. Male or female patients aged 18 to 75 years (at screening), inclusive
2. Have had UC diagnosed at least 3 months prior to first investigational drug administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report (note: endoscopy and histopathology may be performed at Screening if no prior report is readily available).
3. Evidence of UC extending * 15 cm from the anal verge as determined by Baseline
endoscopy (flexible sigmoidoscopy or colonoscopy)
4. Have active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore
of * 2, a rectal bleeding score of * 1, and a stool frequency score * 1
5. Must be currently receiving treatment with at least 1 of the following therapies and
must continue on these therapies during Induction:
* - Oral aminosalicylates at a therapeutic dose for their disease (eg, mesalamine,
sulfasalazine, olsalazine, balsalazide), with the dose stable for at least 3 weeks,
prior to Screening endoscopy
* - Prednisone (doses * 20 mg per day) or equivalent receiving a stable dose for at
least 2 weeks prior to Screening endoscopy
* - Budesonide MMX therapy receiving a stable dose for at least 2 weeks prior to screening endoscopy.
6. Have undergone colonoscopy (or are willing to undergo colonoscopy during Screening):
- within the past 2 years, to screen for dysplasia (unless otherwise recommended by local and national guidelines) if the patient has had left-sided colitis of > 12 years duration or total / extensive colitis of > 8 years duration
- within the past 5 years, to screen for polyps if the patient age is > 45 years
7. If oral aminosalicylates or corticosteroids have been recently discontinued, they must
have been stopped for at least 2 weeks prior to the endoscopy used for Baseline Mayo
Score
8. Female patients of childbearing potential:
Must agree to practice a highly effective method of contraception throughout the trial until completion of the 75- day safety follow-up visit. Highly effective methods of contraception are those that alone or in
combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly. Acceptable methods of birth control in the trial are the following:
-combined hormonal (oestrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
-progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
-placement of an intrauterine device (IUD)
-placement of an intrauterine hormone-releasing system (IUS)
-bilateral tubal occlusion
-vasectomised partner
-sexual abstinence;Male patients:
Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study until completion of the 75-day safety follow-up visit.;All patients:
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception.
Female condom and male condom should not be used together.
9. Must provide written informed consent and have the ability to be compliant with the schedule of protocol assessments
10. Patients must have documentation of positive Varicella zoster virus IgG antibody
status or complete Varicella zoster virus vaccination at least 30 days prior to
randomization
Exclusion criteria
1. Have severe extensive colitis as evidenced by:
* Physician judgment that the patient is likely to require colectomy or ileostomy
within 12 weeks of Baseline
* Current or recent (within 3 months) evidence of fulminant colitis, toxic
megacolon, or bowel perforation
2. Diagnosis of Crohn*s disease or indeterminate colitis or the presence or history of
a fistula consistent with Crohn*s disease or microscopic colitis or radiation colitis or
ischemic colitis
3. Have positive stool examination for pathogens (ova and parasites, bacteria) or
positive test for toxin producing Clostridium difficile (C. difficile) at Screening. PCR (polymerase chain reaction) examination of the stool for C. difficile may be used to excude false positives. If positive, patients may be treated and retested. Documentation of a negative test result for pathogens (ova and parisites, bacteria) is required within 60 days of Day 1.
4. Pregnancy, lactation, or a positive serum *-human chorionic gonadotropin (*-hCG) measured during Screning
5. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine,
psychiatric, or other major systemic disease making implementation of the protocol or
interpretation of the trial difficult or that would put the patient at risk by participating
in the trial
6. Clinically relevant cardiovascular conditions, including history or presence of:
* Recent (within the last 6 months) occurrence of myocardial infarction, unstable
angina, stroke, transient ischemic attack, decompensated heart failure requiring
hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe
untreated sleep apnea
* Prolonged Fridericia's corrected QT interval (QTcF; QTcF > 450 msec
for males, > 470 msec for females), or at additional risk for QT interval
prolongation (eg, hypokalemia, hypomagnesemia, congenital long-QT
syndrome)
* Resting HR < bpm when taking vital signs as part of a physical exam at
Screening
7. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with
glycosylated Hb (HbA1c) > 9% , or diabetic patients with significant comorbid
conditions such as retinopathy or nephropathy
8. History of uveitis (within the last year) or macular edema
9. Known active bacterial, viral, fungal, mycobacterial infection, or other infection
(including tuberculosis or atypical mycobacterial disease [but excluding fungal
infection of nail beds, minor upper respiratory tract infections and minor skin
infections]) or any major episode of infection that required hospitalization or
treatment with intravenous antibiotics within 30 days of Screening or oral antibiotics
within 14 days of Screening
10. History of cancer, including solid tumors and hematological malignancies (except
basal cell and in situ squamous cell carcinomas of the skin or uterine cervix that have
been excised and resolved) or colonic mucosal dysplasia
11. History of alcohol or drug abuse within 1 year prior to randomization;Exclusions Related to Medications:;12. History of treatment with a biologic agent within 8 weeks or 5 elimination half-lives (whichever is less) of that agent prior to randomization
13. History of treatment with an investigational agent within 5 elimination half-lives of
that agent prior to randomization
14. History of treatment with topical rectal 5-aminosalicylic acid or topical rectal steroids
within 2 weeks of Screening endoscopy or anti-motility medications (such as diphenoxylate/atropine) during Screening
15. Receipt of a live vaccine or live attenuated vaccine within 4 weeks prior to randomization
16. Planned concurrent treatment with immunosuppressive agents (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate) after randomization. Patients receiving AZA, 6-MP, or methotrexate at Screening must discontinue treatment with these agents prior to randomization
17. Treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with two or more agents in combination known to prolong PR interval
18. Patients who were primary non-responders to 2 or more biologic agents approved for the treatment of UC (eg, anti-TNF agents or vedolizumab);Exclusions Related to Laboratory Results:;19. Serum creatinine * 1.4 mg/dL for females or * 1.6 mg/dL for males
20. Liver function impairment or persisting elevations of AST or ALT * 2 times
the ULN, or direct bilirubin * 1.5 times the ULN
21. Platelet count * 100,000/µL
22. Hemoglobin * 8.5 g/dL
23. Neutrophils * 1500 /µL
24. Absolute white blood cell count * 3500 /µL
25. Absolute lymphocyte count * 800/µL
26. ECG showing any clinically significant abnormality
27. Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC)
< 70% of predicted values at screening
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 | EUCTR2015-000319-41-NL |
| ClinicalTrials.gov | NCT02435992 |
| CCMO | NL53430.029.15 |