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Trial record 1 of 1 for:    nct05683496
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Efficacy and Safety of VB421 in Subjects With Thyroid Eye Disease (TED) (TED)

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ClinicalTrials.gov Identifier: NCT05683496
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
ValenzaBio, Inc.

Study Description
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Brief Summary:
Phase 1b, multicenter, double-masked, placebo-controlled, randomized, MAD clinical study is designed to evaluate VB421 versus placebo in subjects with TED.

Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Drug: VB421 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Up to 3 cohorts are planned, with each cohort receiving one of 3 different treatment doses
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-masked, placebo-controlled
Primary Purpose: Treatment
Official Title: A Phase 1b, Randomized, Double-Masked, Placebo-Controlled, Multiple Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of VB421 in Subjects With Thyroid Eye Disease (TED)
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Single SC injection of 20mg of VB421 or placebo at Day 1 and Day 21
 Drug: VB421
subcutaneous injection

Drug: Placebo
subcutaneous injection
Experimental: Cohort 2
Single SC injection of 125mg of VB421 or placebo at Day 1 and Day 21
 Drug: VB421
subcutaneous injection

Drug: Placebo
subcutaneous injection
Experimental: Cohort 3
Single SC injection of 250mg of VB421 or placebo at Day 1 and Day 21
 Drug: VB421
subcutaneous injection

Drug: Placebo
subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 113 ]
    Safety and Tolerability

  2. Incidence and characterization of serious treatment emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 113 ]
    Safety and Tolerability


Secondary Outcome Measures :
  1. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Area under the concentration-time curve from time zero to the infinity (AUCO-inf)

  2. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Maximum observed concentration (Cmax)

  3. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Time of observed Cmax (Tmax)

  4. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Area under the concentration- time curve from time zero to the last quantifiable concentration (AUCO-last)

  5. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Elimination half-life (T1/2 el)

  6. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Elimination rate constant (Kel)

  7. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Total body clearance (CL/F)

  8. PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]
    Volume of distribution (Vz/F)

  9. Proportion of subjects that develop anti-drug antibodies (ADAs) after administration of multiple doses of VB421 [ Time Frame: Day 1 to Day 113 ]
    Pharmacokinetic and Pharmacodynamic data


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female, ≥18 and ≤65 years of age.
  • Proptosis defined in the study eye as ≥3 mm above normal.
  • Clinical Activity Score (CAS) ≥4 (using a 7-item scale) for the most severely affected eye
  • Onset of active TED symptoms within 24 months prior to the baseline
  • Must agree to use highly effective contraception as specified in the protocol

Key Exclusion Criteria:

  • Biopsy-proven or clinically suspected inflammatory bowel disease or irritable bowel syndrome.
  • Clinically significant pathology related to hearing
  • Corneal decompensation unresponsive to medical management.
  • Previous orbital irradiation (for any cause) or any previous surgical treatment for TED.
  • Subjects with diabetes or hemoglobin A1c >6.0%.
  • Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to >3 g of methylprednisolone for the treatment of TED.
  • Previous steroid use (IV or oral) specifically for the treatment of TED not to exceed 1 g total dose in the 8 weeks prior to Screening.
  • Previous use of teprotumumab or any other IGF-1 receptor (IGF-1R) inhibitor.
  • Any previous treatment with a biologic drug for the treatment of TED (eg, rituximab and tocilizumab).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05683496


Contacts
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Contact: Keenan, MD 301-755-9900 clinicaltrials@valenzabiotech.com

Locations
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United States, California
Clinical Research Site Recruiting
Beverly Hills, California, United States, 90402
United States, Florida
Clinical Research Site Recruiting
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
ValenzaBio, Inc.
Investigators
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Study Director: Keenan, MD ValenzaBio, Inc.
More Information
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Responsible Party: ValenzaBio, Inc.
ClinicalTrials.gov Identifier: NCT05683496    
Other Study ID Numbers: 421-01-02
First Posted: January 13, 2023    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ValenzaBio, Inc.:
TED
Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
 Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases