Clincosm LogoSign in Get a demo

Efficacy and Safety of VB421 in Subjects With Thyroid Eye Disease (TED)

Sponsor
ValenzaBio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05683496
Collaborator
(none)
36
Enrollment
2
Locations
3
Arms
11
Anticipated Duration (Months)
18
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 dosesUp 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)
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) [Day 1 to Day 113]

    Safety and Tolerability

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

    Safety and Tolerability

Secondary Outcome Measures

  1. PK profile of VB421 [Day 1 to Day 113]

    Area under the concentration-time curve from time zero to the infinity (AUCO-inf)

  2. PK profile of VB421 [Day 1 to Day 113]

    Maximum observed concentration (Cmax)

  3. PK profile of VB421 [Day 1 to Day 113]

    Time of observed Cmax (Tmax)

  4. PK profile of VB421 [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 [Day 1 to Day 113]

    Elimination half-life (T1/2 el)

  6. PK profile of VB421 [Day 1 to Day 113]

    Elimination rate constant (Kel)

  7. PK profile of VB421 [Day 1 to Day 113]

    Total body clearance (CL/F)

  8. PK profile of VB421 [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 [Day 1 to Day 113]

    Pharmacokinetic and Pharmacodynamic data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Site Beverly Hills California United States 90402
2 Clinical Research Site Jacksonville Florida United States 32216

Sponsors and Collaborators

  • ValenzaBio, Inc.

Investigators

  • Study Director: Keenan, MD, ValenzaBio, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ValenzaBio, Inc.
ClinicalTrials.gov Identifier:
NCT05683496
Other Study ID Numbers:
  • 421-01-02
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases

Study Results

No Results Posted as of Jan 13, 2023