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A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)

Primary Purpose

Thyroid Eye Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VRDN-001 Phase 1/2 MAD (HV and TED)
VRDN-001 Phase 3 Cohort (THRIVE)
VRDN-001 Phase 3 Cohort (THRIVE) or Placebo
Sponsored by
Viridian Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Graves Ophthalmopathy, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria for Healthy Volunteers:

  • Must be free of clinically significant disease or medical conditions as determined by the Investigator
  • Female volunteers must not be of child-bearing potential

Key Exclusion Criteria for Healthy Volunteers:

• Must not have a history of or any evidence of diabetes mellitus, recently diagnosed renal impairment or inflammatory bowel disease, or clinically significant ear pathology or hearing impairment

Key Inclusion Criteria for Participants with TED:

  • Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 1 year prior to screening
  • Must have Clinical Activity Score (CAS) of ≥ 4 on the 7-item scale for the study (more proptotic) eye
  • Must agree to use highly effective contraception as specified in the protocol
  • Female TED participants must have a negative serum pregnancy test

Key Exclusion Criteria for Participants with TED:

  • Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
  • Must not have used oral corticosteroids within 4 weeks prior to Day 1
  • Must not have received rituximab, tocilizumab or other immunosuppressive agents within 90 days prior to Day 1
  • Must not have evidence of optic nerve involvement within the previous 6 months
  • Must not have corneal decompensation in the study eye unresponsive to medical management
  • Must not have had previous orbital irradiation or surgery for TED in the study eye
  • Must not have a history inflammatory bowel disease, or clinically significant ear pathology or hearing impairment
  • Must not have received an investigational agent for any condition within 60 days
  • Female TED participants must not be pregnant or lactating

Sites / Locations

  • The Private Office of Raymond Douglas, MD, PhDRecruiting
  • USC Roski Eye InstituteRecruiting
  • Byers Eye Institute/Stanford UniversityRecruiting
  • Senta ClinicRecruiting
  • University of California, San Francisco
  • University of California, San FranciscoRecruiting
  • University of Colorado - Department of OphthalmologyRecruiting
  • University of Florida Bascom Palmer Eye CenterRecruiting
  • Sarasota Retina InstituteRecruiting
  • Emory University Eye CenterRecruiting
  • Massachusetts Eye and EarRecruiting
  • Michigan State University - Department of Neurology and OphthalmologyRecruiting
  • University of Minnesota Eye ClinicRecruiting
  • Washington University St. LouisRecruiting
  • TKL Research, Inc.Recruiting
  • Rutgers New Jersey Medical School - Department of Ophthalmology & Visual ScienceRecruiting
  • Duke Eye CenterRecruiting
  • Scheie Eye Institute Dept of OPH University of PennsylvaniaRecruiting
  • Department of Neuro-Ophthalmology Wills Eye HospitalRecruiting
  • UPMC Eye CenterRecruiting
  • Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.Recruiting
  • Baylor College of Medicine - Alkek Eye CenterRecruiting
  • Moran Eye CenterRecruiting
  • University of Washington - Department of OphthalmologyRecruiting
  • Marshall Health Dept of Clinical & Translational Sciences
  • Oshawa ClinicRecruiting
  • University of Ottawa Eye Institute - The Ottawa Hospital Research InstituteRecruiting
  • Ottawa Hospital Research Institute (OHRI)
  • Charité Universitaetsmedizin BerlinRecruiting
  • Klinik und Poliklinik für AugenheilkundeRecruiting
  • Istituto Auxologico ItalianoRecruiting
  • Istituto Auxologico Italiano
  • Amsterdam University Medical CenterRecruiting
  • Erasmus MCRecruiting
  • Eye Research Department South Wing St Thomas' HospitalRecruiting
  • Eye Research Department South Wing St Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1/2 MAD (HV and TED)

Phase 3 Cohort (THRIVE)

Arm Description

Healthy participants and participants with TED will be randomized to receive two intravenous infusions of VRDN-001 or placebo with an interval of 3 weeks.

Participants with TED will be randomized to either VRDN-001 10mg/kg or placebo.

Outcomes

Primary Outcome Measures

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Proptosis responder rate
Proportion of TED participants with a reduction of proptosis of ≥ 2 mm from baseline as determined by exophthalmometer

Secondary Outcome Measures

Change from baseline in measurement of proptosis as determined by exophthalmometer
Change from baseline in volume of orbital fat as determined by MRI
Change from baseline in volume of extraocular muscles as determined by MRI
Change from baseline in facial fat volume as determined by MRI
Change from baseline in Clinical Activity Score (CAS)
Each of 7 clinical signs and symptoms of ocular inflammation is scored as present or absent (score of 1 or 0, respectively). The CAS is the sum of the individual scores (range from 0 to 7) where a higher score indicates a greater level of inflammation.
Change from baseline in Subjective Diplopia Score
Diplopia grade is assessed using the Gorman Subjective Diplopia Score (range from 0 to 3) based on verbal responses by the study subject. A higher score indicates a worse diplopia grade.
Change from baseline in Graves Orbitopathy-Quality of Life (GO-QoL) combined score
Change in measurement of proptosis by MRI/CT

Full Information

First Posted
December 15, 2021
Last Updated
September 14, 2023
Sponsor
Viridian Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05176639
Brief Title
A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)
Official Title
A Multiple Ascending Dose (MAD) Safety, Tolerability and Efficacy Study of VRDN 001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Normal Healthy Volunteers (HV(s) and Participants With Thyroid Eye Disease (TED)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viridian Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). This clinical trial will evaluate the safety, tolerability and pharmacokinetics (the concentration of drug in the blood over time) of VRDN-001 in healthy volunteers and in patients with TED. Study participants with TED will also be evaluated over time for changes in their signs and symptoms of TED compared to their baseline measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease
Keywords
Graves Ophthalmopathy, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1/2 MAD (HV and TED)
Arm Type
Experimental
Arm Description
Healthy participants and participants with TED will be randomized to receive two intravenous infusions of VRDN-001 or placebo with an interval of 3 weeks.
Arm Title
Phase 3 Cohort (THRIVE)
Arm Type
Experimental
Arm Description
Participants with TED will be randomized to either VRDN-001 10mg/kg or placebo.
Intervention Type
Drug
Intervention Name(s)
VRDN-001 Phase 1/2 MAD (HV and TED)
Intervention Description
2 Infusions of multiple ascending doses of VRDN-001, ranging from 3 mg/kg to 20 mg/kg
Intervention Type
Drug
Intervention Name(s)
VRDN-001 Phase 3 Cohort (THRIVE)
Intervention Description
5 Infusions of VRDN-001 10mg/kg or placebo
Intervention Type
Drug
Intervention Name(s)
VRDN-001 Phase 3 Cohort (THRIVE) or Placebo
Intervention Description
5 Infusions of VRDN-001 10mg/kg or placebo
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Time Frame
Up to Day 50 for MAD healthy volunteers, up to Day 169 for MAD TED subjects, and up to Week 52 for the Phase 3 study subjects
Title
Proptosis responder rate
Description
Proportion of TED participants with a reduction of proptosis of ≥ 2 mm from baseline as determined by exophthalmometer
Time Frame
Week 6 for MAD TED participants, and Week 15 for Phase 3 study subjects
Secondary Outcome Measure Information:
Title
Change from baseline in measurement of proptosis as determined by exophthalmometer
Time Frame
Up to Week 12 for MAD TED subjects, and up to Week 52 for Phase 3 subjects
Title
Change from baseline in volume of orbital fat as determined by MRI
Time Frame
Up to Week 12 for MAD TED participants, and up to Week 52 for Phase 3 subjects
Title
Change from baseline in volume of extraocular muscles as determined by MRI
Time Frame
Up to Week 12 for MAD TED participants, and up to Week 52 for Phase 3 subjects
Title
Change from baseline in facial fat volume as determined by MRI
Time Frame
Up to Week 12 for MAD TED participants, and up to Week 52 for Phase 3 subjects
Title
Change from baseline in Clinical Activity Score (CAS)
Description
Each of 7 clinical signs and symptoms of ocular inflammation is scored as present or absent (score of 1 or 0, respectively). The CAS is the sum of the individual scores (range from 0 to 7) where a higher score indicates a greater level of inflammation.
Time Frame
Up to Week 12 for MAD TED participants, and up to Week 52 for Phase 3 subjects
Title
Change from baseline in Subjective Diplopia Score
Description
Diplopia grade is assessed using the Gorman Subjective Diplopia Score (range from 0 to 3) based on verbal responses by the study subject. A higher score indicates a worse diplopia grade.
Time Frame
Up to Week 12 for MAD TED participants, and up to Week 52 for Phase 3 subjects
Title
Change from baseline in Graves Orbitopathy-Quality of Life (GO-QoL) combined score
Time Frame
Up to Week 12 for MAD TED participants, and up to Week 52 for Phase 3 subjects
Title
Change in measurement of proptosis by MRI/CT
Time Frame
Up to Week 12 for MAD TED participants, and up to Week 52 for Phase 3 subjects
Other Pre-specified Outcome Measures:
Title
VRDN-001 concentrations in the blood over time
Time Frame
Up to Day 155 for MAD participants and up to Week 22 for Phase 3 subjects
Title
Incidence of anti-drug antibody (ADA) development in VRDN-001-treated subjects over time
Time Frame
Up to Day 155 for MAD participants and up to Week 22 for Phase 3 subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria for Healthy Volunteers: Must be free of clinically significant disease or medical conditions as determined by the Investigator Female volunteers must not be of child-bearing potential Key Exclusion Criteria for Healthy Volunteers: ∙ Must not have a history of or any evidence of diabetes mellitus, recently diagnosed renal impairment or inflammatory bowel disease, or clinically significant ear pathology or earing impairment Key Inclusion Criteria for Participants with TED in Phase 1/2 MAD cohorts: Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 1 year prior to screening OR moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began over 1 year prior to screening Must have active TED and a Clinical Activity Score (CAS) of ≥ 4 on the 7-item scale for the study (more proptotic) eye OR chronic TED with no CAS requirement Must agree to use highly effective contraception as specified in the protocol Female TED participants must have a negative serum pregnancy test Key Exclusion Criteria for Participants with TED in Phase 1/2 MAD cohorts: Must not have received prior treatment with another anti-IGF-1R monoclonal antibody Must not have used oral corticosteroids within 4 weeks prior to Day 1 Must not have received rituximab, tocilizumab or other immunosuppressive agents within 90 days prior to Day 1 Must not have evidence of optic nerve involvement within the previous 6 months Must not have corneal decompensation in the study eye unresponsive to medical management Must not have had previous orbital irradiation or surgery for TED in the study eye Must not have a history inflammatory bowel disease Must not have clinically significant ear pathology or hearing impairment Must not have received an investigational agent for any condition within 60 days Female TED participants must not be pregnant or lactating Key Inclusion Criteria for Participants with TED in Phase 3 study: Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study (more proptotic) eye Must agree to use highly effective contraception as specified in the protocol Female TED participants must have a negative serum pregnancy test Key Exclusion Criteria for Participants with TED in Phase 3 study: Must not have received prior treatment with another anti-IGF-1R monoclonal antibody Must not have used oral corticosteroids within 2 weeks prior to Day 1 Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1 Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results Must not have had previous orbital irradiation or surgery for TED in the study eye Must not have a history inflammatory bowel disease Must not have a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss Must not have received an investigational agent for any condition Female TED participants must not be pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viridian Therapeutics
Phone
617-272-4609
Email
viridian-clinical-trials@viridiantherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barrett Katz, MD, MBA
Organizational Affiliation
Viridian Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Private Office of Raymond Douglas, MD, PhD
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Douglas
Phone
559-540-1400
First Name & Middle Initial & Last Name & Degree
Raymond Douglas
Facility Name
USC Roski Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Zhang-Nunes
Phone
323-442-6490
Facility Name
Byers Eye Institute/Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Kossler
Phone
650-498-8790
First Name & Middle Initial & Last Name & Degree
Andrea Kossler
Facility Name
Senta Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
95207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Cockerham
Phone
858-925-3363
First Name & Middle Initial & Last Name & Degree
Kimberly Cockerham
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Winn
Phone
443-494-9486
First Name & Middle Initial & Last Name & Degree
Brian Winn
Facility Name
University of Colorado - Department of Ophthalmology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prem Subramanian
Phone
720-848-6989
First Name & Middle Initial & Last Name & Degree
Prem Subramanian
Facility Name
University of Florida Bascom Palmer Eye Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Lee
Phone
305-326-6508
First Name & Middle Initial & Last Name & Degree
Wendy Lee
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jody Abrams
Phone
941-921-5335
Ext
232
First Name & Middle Initial & Last Name & Degree
Jody Abrams
Facility Name
Emory University Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam De La Garza
Phone
404-778-4430
First Name & Middle Initial & Last Name & Degree
Adam De La Garza
Facility Name
Massachusetts Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Yoon
Phone
617-573-3780
First Name & Middle Initial & Last Name & Degree
Michael Yoon
Facility Name
Michigan State University - Department of Neurology and Ophthalmology
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kaufman
Phone
517-884-8920
First Name & Middle Initial & Last Name & Degree
David Kaufman
Facility Name
University of Minnesota Eye Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Harrison
Phone
612-625-4120
First Name & Middle Initial & Last Name & Degree
Andrew Harrison
Facility Name
Washington University St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Couch
Phone
314-273-3557
Facility Name
TKL Research, Inc.
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers New Jersey Medical School - Department of Ophthalmology & Visual Science
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roget Turbin
Phone
973-972-8367
First Name & Middle Initial & Last Name & Degree
Roget Turbin
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
22710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantal Boisvert
Phone
919-681-1572
First Name & Middle Initial & Last Name & Degree
Chantal Boisvert
Facility Name
Scheie Eye Institute Dept of OPH University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhura Tamhankar
Phone
215-662-8038
First Name & Middle Initial & Last Name & Degree
Madhura Tamhankar
Facility Name
Department of Neuro-Ophthalmology Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark L. Moster, M.D.
Phone
215-928-3130
First Name & Middle Initial & Last Name & Degree
Mark L. Moster, M.D
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Stefko
Phone
412-605-1541
First Name & Middle Initial & Last Name & Degree
Susan Stefko
Facility Name
Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Tang
Phone
346-429-4135
First Name & Middle Initial & Last Name & Degree
Rosa Tang
Facility Name
Baylor College of Medicine - Alkek Eye Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Yen
Phone
713-798-7692
First Name & Middle Initial & Last Name & Degree
Michael Yen
Facility Name
Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley Katz
Phone
801-213-3461
First Name & Middle Initial & Last Name & Degree
Bradley Katz
Facility Name
University of Washington - Department of Ophthalmology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghu Mudumbai
Phone
206-520-9728
First Name & Middle Initial & Last Name & Degree
Raghu Mudumbai
Facility Name
Marshall Health Dept of Clinical & Translational Sciences
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Completed
Facility Name
Oshawa Clinic
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Navdeep Nijhawan
Phone
905-721-4906
First Name & Middle Initial & Last Name & Degree
Navdeep Nijhawan
Facility Name
University of Ottawa Eye Institute - The Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Jordan
Phone
613-737-8899
Ext
72001
Facility Name
Ottawa Hospital Research Institute (OHRI)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KlH 8L6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Charité Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eckart Bertelmann
Phone
49 30 450 654 217
Facility Name
Klinik und Poliklinik für Augenheilkunde
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Sandner
Phone
+49 (0) 351 458 193 85
Facility Name
Istituto Auxologico Italiano
City
Milan
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Fugazzola
Phone
39 02 619112271
First Name & Middle Initial & Last Name & Degree
Laura Fugazzola
Facility Name
Istituto Auxologico Italiano
City
Milan
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Amsterdam University Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peerooz Saeed
Phone
31 20 5668618
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Medici
Phone
+31 10 7035956
Facility Name
Eye Research Department South Wing St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susie Morley
Phone
(00)442071889613
Facility Name
Eye Research Department South Wing St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)

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