Back to resultsA Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Primary Purpose
Diabetic Retinopathy
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AKST4290
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring CCR3 inhibition, Diabetic Retinopathy, Oral Treatment
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- Type 1 or type 2 DM.
- BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
- Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).
Exclusion Criteria:
- Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
- PRP or grid laser within 1000 microns of the foveal center.
- CI-DME on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
- Prior Intraocular of periocular steroid Injection
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
- History of vitreoretinal surgery.
- History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- History of DME or DR treatment with laser or intraocular injections of medication.
- Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
- Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
- Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).
- Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.
Sites / Locations
- Site 132
- Site 136
- Site 123
- Site 121
- Site 116
- Site 117
- Site 118
- Site 120
- Site 133
- Site 127
- Site 122
- Site 130
- Site 126
- Site 134
- Site 129
- Site 128
- Site 125
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AKST4290
Placebo
Arm Description
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
Subjects will receive matching Placebo, twice daily, for 24 weeks
Outcomes
Primary Outcome Measures
To investigate the efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline.
Secondary Outcome Measures
To investigate additional measures of efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline.
To assess the proportion of participants progressing to (or worsening of) CI-DME, PDR, and/or anterior-segment neovascularization (ASNV).
To assess the time to event of CI-DME, PDR, and/or ASNV requiring treatment.
To assess the overall safety of AKST4290 assessed by the incidence and intenisty of adverse events.
To assess the effect of AKST4290 on diabetic kidney disease as assessed by changes in clinical laboratory values such as estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR).
To evaluate the changes from Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) questionnaire. WPAI outcomes are expressed as percentages, with higher numbers indicating greater impairment and less productivity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05038020
Brief Title
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Official Title
A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
Study terminated due to safety findings which require further analysis before dosing additional participants.
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkahest, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).
Detailed Description
This study is designed to evaluate the efficacy of AKST4290 administered at a total daily dose (TDD) of 800 mg daily (400 mg twice daily [b.i.d.]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy to severe NPDR.
Participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
CCR3 inhibition, Diabetic Retinopathy, Oral Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AKST4290
Arm Type
Experimental
Arm Description
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive matching Placebo, twice daily, for 24 weeks
Intervention Type
Drug
Intervention Name(s)
AKST4290
Intervention Description
Oral AKST4290
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Placebo
Primary Outcome Measure Information:
Title
To investigate the efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
To investigate additional measures of efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline.
Time Frame
Baseline to Week 24 or 28
Title
To assess the proportion of participants progressing to (or worsening of) CI-DME, PDR, and/or anterior-segment neovascularization (ASNV).
Time Frame
Baseline to Week 28
Title
To assess the time to event of CI-DME, PDR, and/or ASNV requiring treatment.
Time Frame
Baseline to Week 28
Title
To assess the overall safety of AKST4290 assessed by the incidence and intenisty of adverse events.
Time Frame
Baseline to Week 28
Title
To assess the effect of AKST4290 on diabetic kidney disease as assessed by changes in clinical laboratory values such as estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR).
Time Frame
Baseline to Week 28
Title
To evaluate the changes from Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) questionnaire. WPAI outcomes are expressed as percentages, with higher numbers indicating greater impairment and less productivity.
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
Type 1 or type 2 DM.
BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).
Exclusion Criteria:
Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
PRP or grid laser within 1000 microns of the foveal center.
CI-DME on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
Prior Intraocular of periocular steroid Injection
Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
History of vitreoretinal surgery.
History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
History of DME or DR treatment with laser or intraocular injections of medication.
Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).
Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkahest Medical Monitor
Organizational Affiliation
Alkahest, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 132
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Site 136
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Site 123
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Site 121
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Site 116
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Site 117
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Site 118
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Site 120
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Site 133
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
Site 127
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Site 122
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Site 130
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Site 126
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Site 134
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Site 129
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Site 128
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Site 125
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
We'll reach out to this number within 24 hrs