A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Not Applicable

Recruiting

Brief Summary: This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)

Detailed Description: This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.

Recruitment & Eligibility

Inclusion Criteria

Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
Not require immediate ophthalmological or orbital surgery in the study eye for any reason
Must agree to use highly effective contraception as specified in the protocol
Female TED participants must have a negative serum pregnancy test at screening

Key

Exclusion Criteria

Must not have received prior treatment with another anti-IGF-1R therapy
Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose
Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose
Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor
Must not have a history of inflammatory bowel disease
Female TED participants must not be pregnant or breastfeeding

Arm && Interventions

Group	Intervention	Description
VRDN-003 every 4 weeks using autoinjector	VRDN-003	6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\]
VRDN-003 every 4 weeks using autoinjector	Autoinjector	6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\]
VRDN-003 every 8 weeks using autoinjector	VRDN-003	3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]
VRDN-003 every 8 weeks using autoinjector	Autoinjector	3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]
VRDN-003 every 8 weeks using vial and syringe	VRDN-003	3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\]

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Event (TEAE) incidence rate	Through Week 24	Treatment Emergent Adverse Event (TEAE) incidence rate

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic outcome measures	Through Week 24	Maximum serum concentration (Cmax) of VRDN-003

Locations (4): United Medical Research Institute
🇺🇸
Inglewood, California, United States
Ilumina Medical Research
🇺🇸
Kissimmee, Florida, United States
Hype Clinical Research, LLC
🇺🇸
Miami, Florida, United States
Fraser Eye Center
🇺🇸
Fraser, Michigan, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Study Coordinator
Contact
310-645-4673
Carmen@drjamespeace.com