This study has been transitioned to CTIS with ID 2024-512244-36-00 check the CTIS register for the current data. The objectives of this are to establish the safety, tolerability, and efficacy of VRDN-001, and the pharmacokinetic (PK) and…
ID
Source
Brief title
Condition
- Other condition
- Eye disorders NEC
Synonym
Health condition
Thyroid Eye Disease (MedRA V23.1, system organ class. 100000004853, classification code: 10084358)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Endpoint in the USA, Canada and China in the Pivotal portion
of the Study (THRIVE):
• Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of >=
2 mm from baseline [without a corresponding increase of >= 2 mm in the fellow
eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e.,
Week 15)
Primary Efficacy Endpoint in Australia, EU and UK in the Pivotal portion of the
Study (THRIVE):
• Overall Responder Rate comprised of Proptosis Responder Rate in the study eye
(i.e., reduction of proptosis of >= 2 mm from baseline [without a corresponding
increase of >= 2 mm in the fellow eye] as measured by exophthalmometer) at 3
weeks post the fifth infusion (i.e., Week 15) and Clinical Activity Responder
Rate in the study eye (i.e., reduction in CAS >= 2 points from baseline [without
a corresponding increase of >= 2 points in the fellow eye]) 3 weeks post the
fifth infusion (i.e., Week 15)
Secondary outcome
Safety Endpoints
• Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored and
recorded throughout the duration of the study. All clinically significant
changes in other safety measurements will be recorded as AEs.
Key Secondary Endpoints in the USA, Canada and China in the Pivotal portion of
the Study (THRIVE):
• Change from baseline in Proptosis in the study eye as measured by
exophthalmometer at Week 15
• Clinical Activity Responder Rate in the study eye at Week 15
• Change from baseline in CAS in the study eye at Week 15
• Overall Responder Rate in the study eye at Week 15
• Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia
Score to 0 from baseline for participants with baseline Diplopia Score >0) at
Week 15
• Proportion of participants with a CAS score of zero or one in the study eye
at Week 15
Key Secondary Endpoints in Australia, EU and UK in the Pivotal portion of the
Study (THRIVE):
• Change from Baseline in proptosis in the studyeye as measured by
exophthalmometer at Week 15
• Change from baseline in CAS in the study eye at Week 15
• Diplopia Resolution Rate at (i.e., reduction in Gorman Subjective Diplopia
Score to 0 from baseline for participants with baseline Gorman Subjective
Diplopia Score >0) Week 15
• Proportion of participants with a CAS score of zero or one in the study eye
at Week 15
Exploratory Endpoints in Australia, Canada, China, EU, UK and USA in the
Pivotal portion of the Study (THRIVE):
• Proptosis Responder Rate in the study eye as measured by exophthalmometer) at
Week 24 (12 weeks post fifth infusion), Week 36 (24 weeks post fifth infusion)
and Week 52
• Proptosis Responder Rate in the fellow eye (i.e., reduction of proptosis of >=
2 mm from baseline as measured by exophthalmometer) at Weeks 15, 24, 36 and 52
• Durability of Proptosis Response in the study eye at Weeks 24, 36 and 52
• Time to First Proptosis Response in the study eye
• Clinical Activity Responder Rate in the study eye at Weeks 24, 36 and 52
• Clinical Activity Responder Rate in the fellow eye at Weeks 15, 24, 36 and 52
• Change from baseline in CAS in the study eye at Weeks 24, 36 and 52
• Change from baseline in CAS in the fellow eye at Weeks 15, 24, 36 and 52
• Time to first CAS Response in the study eye
• Overall Responder Rate in the study eye at Weeks 24, 36 and 52
• Overall Responder Rate in the fellow eye at Weeks 15, 24, 36 and 52
• Time to First Overall Response in the study eye
• Diplopia Resolution Rate at Weeks 24, 36 and 52
• Proportion of participants with a CAS score of zero or one in the study eye
at Weeks 24, 36 and 52
• Proportion of participants with a CAS score of zero or one in the fellow eye
at Weeks 15, 21, 36 and 52
• Proptosis Response Rate in the study eye as measured by magnetic resonance
imaging [MRI] or Computed Tomography [CT - where allowed by local health
authorities] at Weeks 15, 24, 36 and 52
• Change from baseline in the following parameters at Weeks 15, 24, 36 and 52:
o Proptosis in the study eye by MRI (or CT - where allowed by local health
authorities)
o Extraocular muscles in the study eye as determined by MRI (or CT - where
allowed by local health authorities)
o Orbital fat in the study eye as measured by MRI (or CT - where allowed by
local health authorities)
o Manual measurement of lid retraction in the study eye
o Graves* Orbitopathy-Quality of Life (GO-QoL) combined score
o GO-QoL activity subscale
o GO-QoL appearance subscale
o EQ-5D-5L QoL questionnaire
o Visual Acuity (VA)
o Gorman Subjective Diplopia Score
• VRDN-001, IGF-1 and anti-drug antibodies (ADA) at various time points pre-
and post-infusions
Background summary
Thyroid Eye Disease (TED) is an autoimmune condition resulting in varied
presentations which include dry eyes, increased lacrimation, local irritation
and eyelid retraction. As the pathophysiology progresses, signs and symptoms
increase to include proptosis, diplopia, restriction of ductions and versions
and optic nerve compression, with ensuing vision loss.
This constellation of signs and symptoms causes difficulty with working,
driving, reading and other activities of daily living, and leads to
psychosocial distress and social withdrawal. Many patients with TED endure at
least 5 to 7 years of medical and surgical therapy before reaching a point of
stability, transformed physically, emotionally and visually, with overwhelming
dysfunction in their quality of life.
Treatment during the active phase of the disease focuses on preserving sight
and the integrity of the cornea as well as anti-inflammatory measures. There
had been no direct therapy available for the diplopia and proptosis, or
periorbital edema and lid retraction.
Current treatments of TED are generally incomplete and unsatisfactory both for
the patient and treating physicians. As symptoms and signs become more severe,
the only alternatives were extraocular muscle surgery, orbital radiation and
orbital decompression. Again, even these interventions were incomplete and
often unrewarding.
The principle underlying pathology of TED is the activation of an inflammatory
cascade within the orbital cone, primarily due to autoantibodies against the
thyroid stimulating hormone receptor (TSHR) which has been shown to exhibit
cross talk (transactivation) with the IGF-1R. Transactivation between the TSHR
and the IGF-1R forms the basis for the therapeutic use of anti-IGF-1R mAbs in
TED.
The anti-IGF-1R approach has proven to be clinically valuable. Teprotumumab, a
mAb directed against the IGF-1 receptor, was shown to be effective in reducing
proptosis, diplopia and inflammation in patients with active TED. Therefore,
VRDN-001, also a mAb directed against the IGF-1 receptor, may provide
therapeutic benefit in TED patients.
In this study the safety, tolerability, and efficacy of VRDN-001 are
investigated, as well as the pharmacokinetic (PK) and pharmacodynamic (PD)
profiles in HV and TED patients over a dose range of 3.0 to 20.0 mg/kg.
The rationale for selecting 5 infusions as the dosing regimen in the active TED
pivotal portion of the study (THRIVE) is based on available interim VRDN-001
data and published information for teprotumumab have demonstrated that more
than 90% of the proptosis response is observed following the first 5 infusions
with minimal further improvement thereafter. Furthermore, in the VRDN-001-101
active TED MAD study, the time to a proptosis response, defined as a reduction
from baseline of 2 mm in the study eye (without an increase of 2 mm in the
fellow eye) as measured by exophthalmometer, occurred between 3 to 4 weeks
compared to the median time of response of 6.4 weeks for teprotumumab. This
correlated with the time to a reduction in the clinical signs and symptoms
(CAS) to a score of 0 or 1 which also occurred between week 3 and 4 in the
VRDN-001-101 active TED MAD study. These results suggest that the required
duration of treatment with VRDN-001 may be less than seen with teprotumumab.
Study objective
This study has been transitioned to CTIS with ID 2024-512244-36-00 check the CTIS register for the current data.
The objectives of this are to establish the safety, tolerability, and efficacy
of VRDN-001, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of
VRDN-001 in HV and TED patients over a dose range of 3.0 to 20.0 mg/kg.
Study design
The study design will be randomized, double-masked, and placebo-controlled,
where both participants and site personnel (except pharmacy personnel preparing
the infusate) will be masked to treatment, and the sponsor will not be masked.
The MAD studyparticipants will be comprised of both HVs and participants with
TED. In the EU only patients with TED will be included in the study (no healthy
volunteers).
Three dose levels will be evaluated in HVs and active TED MAD subjects: 3.0
(low), 10.0 (middle), and 20.0 (high) mg/kg. Each participant will receive two
doses administered by intravenous infusions, 3 weeks apart. The low dose cohort
will be comprised of 4 NHVs randomized 3:1 (VRDN-001: placebo) and the middle
and high dose cohorts will be comprised of 4 HVs and 8 participants with active
TED with each group randomized 3:1 (VRDN-001: placebo). An independent Data
Safety Monitoring Board (DSMB) will decide on whether dose escalation can
occur, from low dose to middle dose and middle dose to high dose, one week
after the fourth HV participant at each dose level completes their second
infusion. The low dose level will enroll 4 HVs, randomized 3:1 (VRDN-001:
placebo). Two HV subjects (*sentinel* participants) at the low dose level will
be treated and followed through 1 week after their first infusion before the
next 2 HV low dose participants are treated. If a Dose-Limiting Toxicity (DLT)
(defined as an Adverse Event [AE] with a severity >= Grade 3 on the Common
Terminology Criteria for Adverse Events [CTCAE] scale [reference Appendix 3 in
protocol]) occurs in any of the HV low dose participants receiving active drug,
a second cohort of 4 HVs will be enrolled, randomized 3:1 (VRDN 001: placebo),
and treated at the low dose to confirm that there are no additional DLTs before
dose escalation. In the case of a Grade 4 related toxicity in any participant,
the participant will be withdrawn from treatment and the independent Data
Safety Monitoring Board (DSMB) will review the data and provide their
recommendations. At the middle dose level, in parallel to the safety evaluation
in HVs, the study will begin enrolling active TED participants after the first
two sentinel HV participants at the middle dose level have been treated and
followed for one week following their first dose. If a DLT occurs in any of the
HV middle dose participants receiving active drug, then dose escalation will
not occur until all 8 active TED participants have been treated without a
further DLT. The investigators will be involved in the decision to dose
escalate, or not, in conjunction with the DSMB. If dose escalation of the HVs
from the middle to the high dose has occurred while the active TED participants
continue to be treated at the middle dose level and a second DLT occurs at the
middle dose level, then further treatments at the middle and high dose levels
will be immediately discontinued and the Maximum Tolerated Dose (MTD) will be
considered to be the low dose level. The MTD will be defined as the dose at
which not more than 1 DLT occurred and no further treatments will occur at a
higher dose level than the MTD. Similarly, at the high dose level, in parallel
to the safety evaluation in HVs, the study will begin enrolling active TED
participants after the first two sentinel HV participants at the high dose
level have been treated and followed for one week following their first dose.
If more than one DLT occurs among the HV and active TED participants at the
high dose level, the middle dose will be considered the MTD. If the highest
dose is selected as MTD, and middle and high doses exhibit similar evidence of
clinical activity in terms of proptosis response rate, then 8 active TED
participants may be enrolled at the low dose (3.0 mg/kg) and based on those
data a further cohort of 8 active TED participants may also be enrolled at a
low-intermediate dose (5.0 mg/kg), with both cohorts randomized 3:1
(VRDN-001:placebo), in order to establish a dose response curve for clinical
activity.
Two additional cohorts of participants with chronic TED (defined as those
participants with symptoms of TED occurring more than 1 year prior to entry to
the study), will also be enrolled and treated with 10 mg/kg VRDN-001 and
another dose (to be selected following the results of the active TED MAD
cohorts), respectively. Both cohorts will be randomized 3:1 (VRDN-001:
placebo), and the cohorts may be enrolled sequentially at any time after
completion of enrollment of the 20 mg/kg active TED MAD cohort.
The HV and Active TED MAD portions of the study have been completed. The
Chronic TED MAD portion of the study is fully recruited but remains active.
The pivotal portion of the (THRIVE) will be a randomized, double-masked
(including the sponsor) and placebo-controlled study in active TED participants
whose signs and symptoms declared themselves within 15 months of screening. The
dose selected is 10mg/kg (which is half the maximum tested dose in the active
TED MAD portion of the study). The study will be comprised of 90 participants
(to ensure 78 evaluable participants at the primary endpoint at 3 weeks post
the fifth infusion (i.e., Week 15) randomized with an allocation ratio of 2:1,
(60 participants active: 30 participants placebo), stratified at baseline by
level of proptosis (> or equal to 23 mm, Y/N), and will compare the efficacy of
5 infusions of 10 mg/kg VRDN-001 administered at 3-week intervals to placebo.
Participants in the pivotal portion of this study (THRIVE) were either
randomized (1:1:1) to 5 infusions or 8 infusions versus placebo (as per all
previous versions 7.0 and before of the VRND-001-101 protocol) or will be
randomized (2:1) to 5 infusions versus placebo, since version 8.0 of the
protocol), each administered as IV infusions at 3- week intervals. All
participants will receive a total of 5 to 8 infusions to maintain masking as
determined by the protocol version to which the participants were randomized.
For participants previously randomized to 8 infusions and who have received
greater than 5 infusions, further infusions will be discontinued. The active
TED Pivotal portion of the trial is ongoing.
Participants who are deemed to be non-responders at 3 weeks post the fifth
infusion (i.e., Week 15) in the pivotal portion of the study may be offered the
option to enroll into an open-label treatment study where they will receive 5
further infusions of VRDN-001 at 3-week intervals for a further 12 weeks of
treatment. For some countries, per local health authority requirements
participants may be unmasked prior to the decision to enroll in the open-label
treatment study. A non-responder is defined as either:
*A participant who did not achieve a >= 2 mm reduction from baseline in
proptosis (as measured by exophthalmometer) in the study eye at 3 weeks post
the fifth infusion (i.e., Week 15)
OR
*A participant who achieved a >= 2 mm reduction from baseline in proptosis (as
measured by exophthalmometer) in the study eye but had a corresponding increase
of >= 2 mm from baseline in proptosis in the fellow eye at 3 weeks post the
fifth infusion (i.e., Week 15).
The Day-1/Day 1 visit(s) in the open-label treatment study (separate study
denoted as VRDN-001-302) are to be conducted within 4 weeks of the 3 weeks post
the fifth infusion assessment (i.e., Week 15) in the VRDN-001-101 pivotal study
(THRIVE). More than 4 weeks may be allowed between the completion of the 3
weeks post the fifth infusion assessment (i.e., Week 15) in the piotal study
and the Day-1/Day 1 visit of the open-label treatment study with prior written
approval by the Sponsor.
Measurements will continue to be collected through 52 weeks for those
participants who are deemed to be responders (i.e., did achieve a >=2 mm
reduction in proptosis in the study eye as measured by exophthalmometer) at 3
weeks post the fifth infusion (i.
Intervention
Three dose levels will be evaluated in HVs and active TEDMAD participants. One
group receives an IV infusion twice with VRDN-001 in one of the following
doses: 3.0 (low), 10.0 (middle), and 20.0 (high) mg/kg. Each participant will
receive two doses administered by intravenous infusions, 3 weeks apart. The
other group receives an IV infusion twice as well, with placebo
(saline).Participants in the pivotal portion of this study (THRIVE) were either
randomized (1:1:1) to 5 infusions or 8 infusions versus placebo or will be
randomized (2:1) to 5 infusions versus placebo, each administered as IV
infusions at 3- week intervals. For participants previously randomized to 8
infusions and who have received greater than 5 infusions, further infusions
will be discontinued.
VRDN-001 is a humanized mAb directed to IGF-1R. VRDN-001 will be provided as a
solution containing 25 mg/mL or 50 mg/mL of antibody in 4.0 mL extractable
volume in 10R vials, frozen at -20 ± 5oC.
The pharmacist or other qualified, trained and delegated individual preparing
the infusion bags will be unmasked to treatment and will either dispense 100 mL
(low dose cohort), or 250 mL (middle and high dose cohorts) bags of saline with
or without VRDN-001 added, according to the Randomization and Trial Supply
Management (RTSM) System. The volume of saline removed from the bags will equal
the volume of VRDN-001 added to maintain masking. In the MAD study the bags
will be infused at 2.8 mL per minute which approximates to 36 (±10) and 90
(±15) minutes for the 100 mL and 250 mL bags, respectively. In the pivotal
portion of the study, the 250 mL bags will be infused at 2-3 mL per minute for
the first 15 minutes, then advancing to 8-9 mL per minute thereafter, for the
first infusion which approximates to 40 (±10) minutes. Each subsequent infusion
will be infused at 8-9 mL per minute which approximates to 30 (±10) minutes for
the total infusion.
Study burden and risks
Burden:
Subjects will need to undergo the following procedures/tests:
- IV infusion with study drug (250 ml), mildly invasive, 2 times for MAD cohort
and 5 times for Pivotal cohort, duration max. 90 min.
- eye examinations, mildly invasive, 6 times (MAD cohort) or 10 times (Pivotal
cohort)
- eye/facial MRI, mildly invasive, 4 times for MAD cohort and 5 times for
Pivotal cohort.
- Venapunctures: 11 times (incl 8 PK samples) for MAD cohort or 16 times (incl.
22 PK samples) for Pivotal cohort (41 ml per occasion)
- Physical examination: 2 times (both cohorts)
- Vital signs and ECG: 10 times (MAD cohort) or 23 times (Pivotal cohort)
- Questionnaire: 6 times (MAD cohort) or 10 times (Pivotal cohort)
- Facial photography to assess gaze: 4 times (both cohorts)
- Hearing test: 5 times (MAD cohort) or 10 times (Pivotal cohort)
Other relevant instructions/behavioral rules are:
- Use appropriate measures to avoid pregnancy (both male and female
participants), if applicable
- Fasted visits: 2 times for MAD cohort and 5 times for Pivotal cohort
(mornings of the IV infusions with study drug).
Risks:
Risks involved are possible side-effects of the study drug, as well as
discomforts as a result of study assessments.
The potential risks of VRDN-001 include:
• Muscle cramps or spasms
• Nausea
• Diarrhea
• High blood sugar
• Hearing impairment including hearing loss
• Headache
• Fatigue
• Dry skin
• Altered sense of taste
• Hair loss
• A reaction at the site of intravenous infusion
• Worsening of inflammatory bowel disease
• Menstrual Disorders
The following study assessments may cause discomforts for subjects:
• Eye assessments (intraoculair pressure measurement, slit lamp biomicroscopy
and fundoscopy and lid retraction measurement)
• MRI
• Blood drawing
Benefit:
TED is generally recognized as a disease with major impact on the lives of
patients suffering form it. Current treatments of TED are generally incomplete
and unsatisfactory. Many patients with TED, when reaching a point of stability
after years of treatment, are transformed physically, emotionally and visually,
with overwhelming dysfunction in their quality of life.
VRDN-001, as an mAb directed against the IGF-1 receptor, may provide
therapeutic benefit in TED patients. However, there is no guarantee that
participation in the current study will help the participant; the participant
may receive a placebo treatment.
Risk-benefit analysis:
Considering the nature of the disease and its major impact on the lives of
patients suffering from it, and current lack of appropriate treatment options,
as well as taking into account the measures taken to minimize risk to
participants taking part in this study, the potential risks identified in
association with VRDN-001 are justified by the anticipated benefits that may be
afforded to participants with TED.
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Listed location countries
Age
Inclusion criteria
Inclusion Criteria:
Enrollment in the HV and Active TED MAD cohorts has been completed.
The inclusion criteria corresponding to the HV and Active and Chronic TED MAD
cohorts are now described in Appendices 4 and 5 (Protocol V8.0), respectively.
Active TED Pivotal (THRIVE) participants
Participants must:
1. Be able to understand the study procedures and the risks involved and be
willing to provide written informed consent before the first study-related
activity
2. Be an adult male or female participant, at least 18 years of age or older
3. Have had a clinical diagnosis of TED with a CAS of >= 3 on the 7-item scale
for the study eye
4. Have moderate to severe (i.e., has an appreciable impact on daily living)
active TED associated with proptosis of >=3 mm above normal values for race and
gender in the opinion of the investigator and at least one of the following:
lid retraction of >=2 mm, moderate or severe soft tissue involvement, periodic
or constant diplopia, spontaneous retrobulbar pain or pain on eye movement,
swelling of the conjunctiva, eyelids or plica, or redness of the eyelids or
plica in the study eye
5. Have documented evidence of ocular symptoms or signs associated with active
TED that began within 15 months prior to study screening
6. VRDN-001 can be started concomitantly with attempts to achieve euthyroid
status. Underlying thyroid status is not an inclusion criterion.
7. Not require expected immediate surgical ophthalmological or orbital surgery
in the study eye for any reason
8. VRDN-001 can be used with caution in patients with diabetes mellitus.
Diabetic participants should be monitored by their endocrinologist or other
appropriately trained personnel and have at study entry a glycated hemoglobin
(HbA1c) of <8.5%
9. If female, have a negative serum pregnancy test at screening and further
negative urine tests immediately before each dose of study medication following
the last dose of study medication as described in Appendix 1C if the
participant is a woman of childbearing potential (including those with <2 years
since the onset of menopause, amenorrhea for <1 year, or not surgically
sterile); such participants must agree to use an acceptable method of
contraception such as a condom and a second highly effective method of
contraception as described in Section 4.4 from Screening up to and including
100 days after the last dose of study medication. If the participant is
initiating hormonal contraception at time of Screening or within one cycle of
Day 1, participant agrees to use a double-barrier method of contraception until
completing one-full cycle of hormonal contraception. An acceptable
double-barrier combination method is a condom with either diaphragm or sponge
with spermicide
10. Be surgically sterile males for at least 6 weeks, or agree to use an
acceptable method of contraception such as a condom and a second highly
effective method of contraception as described in Section 4.4 from Screening up
to and including 100 days after the last dose of study medication
11. Be willing and able to comply with all the requirements of the protocol for
the entire duration of the study
Exclusion criteria
Exclusion Criteria
Enrollment in the HV and Active TED MAD cohorts has been completed.
The exclusion criteria corresponding to the HV and Active and Chronic TED MAD
cohorts are now described in Appendices 4 and 5 (Protocol V8.0), respectively.
Active TED Pivotal (THRIVE) participants
Participants must not:
1. Have received prior treatment with another anti-IGF-1R therapy or any
investigational agent for TED
2. Have a compressive optic neuropathy of TED that is expected to require
surgical decompression in the immediate future.
3. Have corneal decompensation in the study eye unresponsive to medical
management
4. Have a decrease in CAS of >=2 points in the study eye between screening
assessment and Day -1
5. Have a decrease in proptosis of >=2 mm in the study eye between screening
assessment and Day -1
6. Have had previous orbital irradiation or decompression surgery involving
excision of fat for TED to the study eye*s orbit
7. Have history of or screening audiometry assessment of significant (as
determined by the Investigator) ear pathology, relevant ear surgery or hearing
loss
8. Have inflammatory bowel disease (e.g., biopsy proven or clinical evidence of
inflammatory bowel disease)
9. Have used systemic corticosteroids for any condition, including TED, or
selenium within 2 weeks prior to the first dose of study medication (topical
steroids or multivitamins that contain selenium are permitted)
10. Have received other immunosuppressive agents, including rituximab, or
tocilizumab, for any condition, including TED, within 8 weeks prior to the
first dose of study medication
11. Have received any other therapy for TED within 8 weeks prior to the first
dose of study medication (artificial tears are permitted)
12. Have received an investigational agent for any condition within 8 weeks
prior to the first dose of study medication
13. Have a pre-existing ophthalmic condition in the study eye which in the
opinion of the Investigator, would confound interpretation of the study results
14. Be a pregnant or lactating woman
15. Be an active alcoholic or illicit drug user or considered at high risk of
relapse by the Investigator
16. Have a known hypersensitivity to any of the components of VRDN-001 or
placebo formulations, or prior hypersensitivity to monoclonal antibodies (mAbs)
17. Have any condition, which in the opinion of the Investigator, would
preclude inclusion in the study
18. Have a positive test for human immunodeficiency virus (HIV-1 and HIV-2)
19. Have a positive test for active hepatitis B or hepatitis C infection
20. Have previously participated in this study or any study of VRDN-001
21. French participating sites only: In accordance with the provisions of
articles L.1121-5 et seq. of the Public Health Code, pregnant or breastfeeding
women, persons deprived of their liberty by a judicial or administrative
decision, persons under psychiatric care without their consent, minors and
adults under a legal protection measure must not be included
Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital
decompression surgery limited to bone only are NOT exclusions.
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 | CTIS2024-512244-36-00 |
| EudraCT | EUCTR2021-006794-37-NL |
| ClinicalTrials.gov | NCT05176639 |
| CCMO | NL80863.078.22 |