An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab
A Phase 4, Single-Arm, Open-Label Trial to Evaluate the Safety and Efficacy of Veligrotug in Participants With Thyroid Eye Disease (TED) Who Previously Responded to Teprotumumab
This is a clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but subsequently had a disease recurrence.
연구 개요
상세 설명
This is a Phase 4, single-arm, open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to) clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab but subsequently had disease recurrence.
The primary objective of this trial is to evaluate the safety and tolerability of veligrotug when given as 5 intravenous (IV) infusions of 10 mg/kg administered every 3 weeks. To evaluate safety, the incidence rate of treatment-emergent adverse events (TEAEs) 3 weeks after the fifth infusion (ie, Week 15) will be determined.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: James Sankan
- 전화번호: 781.204.8590
- 이메일: jsankan@viridiantherapeutics.com
연구 장소
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California
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Newport Beach, California, 미국, 92660
- Office of Dr. Amy Patel Jain, MD
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연락하다:
- Study Coordinator
- 전화번호: 248-800-1180
- 이메일: drjain@dramypateljain.com
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Florida
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Sarasota, Florida, 미국, 34239
- Sarasota Retina Institute
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연락하다:
- Study Coordinator
- 전화번호: 941-921-5335
- 이메일: peggy@sarasotaretinainstitute.com
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Massachusetts
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East Weymouth, Massachusetts, 미국, 02189
- Ophthalmic Consultants of Boston
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연락하다:
- Study Coordinator
- 전화번호: 617-314-2732
- 이메일: mforsyth@eyeboston.com
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Michigan
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Livonia, Michigan, 미국, 48152
- Kahana Oculoplastic & Orbital Surgery
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연락하다:
- Study Coordinator
- 전화번호: 248-800-1180
- 이메일: kristin@mioculoplastics.com
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Missouri
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Kansas City, Missouri, 미국, 64108
- University Health
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연락하다:
- Study Coordinator
- 전화번호: 816-218-2582
- 이메일: Bong.nguyen@umkc.edu
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New Jersey
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Somerset, New Jersey, 미국, 08873
- The Center for Eye and Facial Plastic Surgery
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연락하다:
- Study Coordinator
- 전화번호: 609-798-7171
- 이메일: graciela@centerfacialplastics.com
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Texas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine Alkek Eye Center
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연락하다:
- Study Coordinator
- 전화번호: 941-921-5335
- 이메일: Isabella.valli@bcm.edu
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Houston, Texas, 미국, 34239
- Neuro-Eye Clinical Trials
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연락하다:
- Study Coordinator
- 전화번호: 713-942-2187
- 이메일: mtavera@neuroeye.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Must have a diagnosis of TED with associated signs and symptoms.
- Must have completed an initial full course of treatment (8 infusions over approximately 21 weeks) with teprotumumab ≥9 months prior to screening.
- Must have a documented clinical response to teprotumumab.
- Must have evidence of recurrence following the completion of prior teprotumumab treatment course, as measured by exophthalmometer in the study eye.
- Must have a Clinical Activity Score (CAS) ≥3 in the study eye.
- Must not require immediate orbital surgery in the study eye during the anticipated duration of the trial.
- 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 sight-threatening TED (eg, dysthyroid optic neuropathy).
- Must not have received IGF-1R inhibitor therapy within 9 months prior to screening or received any IGF-1R inhibitor other than teprotumumab at any time.
- Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to the first dose.
- Must not have received other immunosuppressive drugs for any condition, including TED, within 12 weeks prior to the first dose or any other therapy for TED (except for artificial tears) within 8 weeks prior to the first dose.
- Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose.
- Must not have 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 trial results.
- Must not have abnormal hearing test before first dose or any history of hearing impairment. Must not also have any history of ear conditions considered significant by the study doctor.
- Must not have a history of inflammatory bowel disease.
- Female participants must not be pregnant or breastfeeding.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 5 IV infusions of 10 mg/kg of veligrotug
Participants will receive veligrotug10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks. |
intravenous infusions
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety and tolerability of veligrotrug (LUMVOA™)
기간: Through Week 15
|
Treatment Emergent Adverse Event (TEAE) incidence rate |
Through Week 15
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VRDN-001-401
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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