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
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|Condition or disease||Intervention/treatment||Phase|
|Thyroid Eye Disease||Drug: VB421 Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|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|
|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|
Experimental: Cohort 1
Single SC injection of 20mg of VB421 or placebo at Day 1 and Day 21
Experimental: Cohort 2
Single SC injection of 125mg of VB421 or placebo at Day 1 and Day 21
Experimental: Cohort 3
Single SC injection of 250mg of VB421 or placebo at Day 1 and Day 21
- Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 113 ]Safety and Tolerability
- Incidence and characterization of serious treatment emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 113 ]Safety and Tolerability
- 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)
- PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]Maximum observed concentration (Cmax)
- PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]Time of observed Cmax (Tmax)
- 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)
- PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]Elimination half-life (T1/2 el)
- PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]Elimination rate constant (Kel)
- PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]Total body clearance (CL/F)
- PK profile of VB421 [ Time Frame: Day 1 to Day 113 ]Volume of distribution (Vz/F)
- 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
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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|
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).
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
|Contact: Keenan, MDemail@example.com|
|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|
|Study Director:||Keenan, MD||ValenzaBio, Inc.|
|Responsible Party:||ValenzaBio, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Endocrine System Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Immune System Diseases