A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)

NCT05038020 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AKST4290-231
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 17

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).

Conditions

Diabetic Retinopathy

Keywords

CCR3 inhibition; Diabetic Retinopathy; Oral Treatment

Outcome Measures

Primary Outcomes (1)

• To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.

  The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR. To be eligible for the study, participants needed to have moderately severe non-proliferative DR (NPDR) (DRSS Level 47) to severe NPDR (DRSS Level 53) in one eye, and at least mild NPDR (DRSS Level 35) to mild proliferative DR (PDR) (DRSS Level 61) in the other eye at baseline. The DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings. The primary efficacy endpoint is the proportion of participants with a ≥ 3-step improvement from baseline on the DRSS score as compared with Week 24.

  Baseline to Week 24

Secondary Outcomes (6)

• To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.

  Baseline to Week 24 or 28

• To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV).

  Baseline to Week 28

• To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.

  Baseline to Week 28

• To Assess the Overall Safety of AKST429

  Baseline to Week 28

• To Assess the Effect of AKST4290 on Diabetic Kidney Disease

  Baseline to Week 28

Study Arms (2)

AKST4290

EXPERIMENTAL

Subjects will receive AKST4290, 400mg twice daily, for 24 weeks

Drug: AKST4290

Placebo

PLACEBO COMPARATOR

Subjects will receive matching Placebo, twice daily, for 24 weeks

Drug: Placebo

Interventions

AKST4290 DRUG

Oral AKST4290

AKST4290

Placebo DRUG

Oral Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Center-InvolvedI-Diabetic Macular Edema (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.

Sponsors & Collaborators

• Alkahest, Inc.: lead

Study Sites (17)

Site 132

Phoenix, Arizona, 85021, United States

Location

Site 136

Phoenix, Arizona, 85053, United States

Location

Site 123

Glendale, California, 91203, United States

Location

Site 121

Huntington Beach, California, 92647, United States

Location

Site 116

Clearwater, Florida, 33761, United States

Location

Site 117

Sarasota, Florida, 34239, United States

Location

Site 118

Winter Haven, Florida, 33880, United States

Location

Site 120

Oak Forest, Illinois, 60452, United States

Location

Site 133

Beaufort, South Carolina, 29902, United States

Location

Site 127

Ladson, South Carolina, 29456, United States

Location

Site 122

Arlington, Texas, 76012, United States

Location

Site 130

Bellaire, Texas, 77401, United States

Location

Site 126

Harlingen, Texas, 78550, United States

Location

Site 134

Houston, Texas, 77025, United States

Location

Site 129

Katy, Texas, 77494, United States

Location

Site 128

San Antonio, Texas, 78240, United States

Location

Site 125

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Limitations and Caveats

This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on low enrollment number, no data is reported in order to protect and maintain participant privacy/confidentiality.

Results Point of Contact

• Title: Head of Communications
• Organization: Alkahest, Inc.

sm-Trials-alkahest@grifols.com

(650) 801-0474

Study Officials

• Alkahest Medical Monitor

  Alkahest, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 8, 2021
• Study Start: August 17, 2021
• Primary Completion: December 9, 2021
• Study Completion: April 19, 2022
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)