A Phase 2, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of AT-02

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02. AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Subject understands the study procedures and can give signed informed consent.

• Subject is willing and able to comply with this protocol and will be available for the entire duration of the study.

• Has a confirmed diagnosis of AL amyloidosis and meets the criteria below:

‣ Histologic confirmation with a biopsy containing deposits of apple-green birefringent, Congophilic material or other amyloid staining (i.e., thioflavin T or sulfated alcian blue) with confirmatory immunohistochemistry or mass spectrometry, AND

⁃ May be receiving maintenance daratumumab and must have achieved and maintained a hematologic very good partial response (VGPR) or complete response (CR), have completed chemotherapy therapy (ie, melphalan, bortezomib, thalidomide, lenalidomide, or cyclophosphamide) and be at least 6 months from first hematologic response (CR or VGPR), AND

⁃ Either

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‣ Screening eGFR ≥20 and ≤75 mL/min/1.73m2 based on CKD-EPI equation, OR

⁃ Proteinuria that is not improving (e.g., \<25% reduction in urine protein creatinine ratio (UPCR) in the last 12 months or since hematologic response, whichever is shorter) with screening urine albumin creatinine ratio (UACR) \>700 mg/g based on central lab assessment of first morning void urine collected at screening and confirmed by a separate Screening 24-hr urine protein \>1.0gm/day; 24-hr urine protein may be repeated once during Screening.

• Note: Participants may meet both eGFR and proteinuria criteria

• Women of childbearing potential (WOCBP):

‣ WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.

⁃ Must not be breastfeeding, lactating, or planning a pregnancy during the study period.

⁃ WOCBP who are not exclusively in same-sex relationships must agree to remain abstinent (complete avoidance of heterosexual intercourse) or use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, during the treatment period and for at least 105 days after the last dose of study intervention.

• Women of non-childbearing potential (WONCBP), and female participants with vasectomized male partners:

‣ WONCBP must agree to remain abstinent (complete avoidance of intercourse) or the male partners of WONCBP participants must wear a condom to protect against the transfer of study intervention through bodily fluids during the treatment period and for at least 105 days after the last dose of study intervention.

⁃ Postmenopausal females must have a documented serum FSH level \>40 mIU/mL at Screening to confirm menopause.

• Male participants:

‣ Male participants must inform their female sexual partners who are WOCBP of the contraceptive requirements of the protocol and are expected to adhere to using contraception with their partner.

⁃ Male participants with female sexual partners who are WOCBP must agree to remain abstinent (complete avoidance of heterosexual intercourse) or use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, during the treatment period and for at least 165 days after the last dose of study intervention.

⁃ Male participants must not donate sperm for at least 165 days after the last dose of study intervention.

⁃ Male participants in same-sex relationships or in relationships with WONCBP, must agree to remain abstinent (complete avoidance of intercourse) or use a condom to prevent exposure of the partner to study intervention through ejaculate/seminal fluid during the treatment period and for at least 165 days after the last dose of study intervention.

Locations
United States
Kansas
Kansas City
RECRUITING
Kansas City
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oregon
OHSU (Oregon Health & Science University)
NOT_YET_RECRUITING
Portland
Pennsylvania
Penn Presbyterian Medical Center
RECRUITING
Philadelphia
Contact Information
Primary
Scott Stephens
sstephens@attralus.com
+1-321-228-7400
Backup
Deepika Aggarwal
deepika.aggarwal@novotech-cro.com
3 9960 7997
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 120
Treatments
Experimental: A (AT-02)
Subjects will receive AT-02 via intravenous infusion once every two or 4 weeks for 104 weeks (52 total AT-02 administrations).
Related Therapeutic Areas
Sponsors
Leads: Attralus, Inc.
Collaborators: Novotech (Australia) Pty Limited

This content was sourced from clinicaltrials.gov