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OCS-05 in Patients With Acute Optic Neuritis (ACUITY)

Primary Purpose

Optic Neuritis, Optic; Neuritis, With Demyelination

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
OCS-05 IV administration
Placebo IV administration
Sponsored by
Oculis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring Acute Optic Neuritis (AON), Demyelination, Optic Neuritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Diagnosed with a unilateral acute optic neuritis with a demyelinating origin
  • Onset of visual loss symptoms in the last 10 days before randomization

Main Exclusion Criteria:

  • Optic neuropathy of non-demyelinating origin
  • Known Neuromyelitis optica with autoantibodies against aquaporin-4 (AQP4-Abs)
  • Patients with widespread and symmetric white matter alterations in the screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders)
  • Active, chronic disease (or stable but treated with immune therapy) of the immune system other than MOG antibody associated disorder (MOGAD) or Multiple Sclerosis (MS) (e.g. Sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency)
  • An alternative cause of visual loss (e.g. compressive or infiltrative lesion of the optic nerve, infections, genetic forms of visual loss.
  • Diagnosed with macular oedema, severe myopia (>6 δ) or other disease of the retina at inclusion
  • Known diabetic retinopathy
  • Known glaucoma
  • Female patients of child-bearing potential who are unwilling to use an effective contraception while enrolled on study and for the duration of the study.
  • Male patients not willing to use contraception (abstinence, condom etc..) while enrolled in the study and receiving the experimental drug, and for at least 2 days after the last experimental drug administration.
  • Breastfeeding or pregnant women

Sites / Locations

  • Hospices Civils de LyonRecruiting
  • CHU - NiceRecruiting
  • CIC Neurosciences - La Pitié SalpêtrièreRecruiting
  • Foundation RothschildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OCS-05

Placebo

Arm Description

Once daily IV infusions of OCS-05 (n=18) for 5 consecutive days

Once daily IV infusions of Placebo (n=18) for 5 consecutive days

Outcomes

Primary Outcome Measures

Number of patients with treatment-related adverse events (frequencies and percentages tabulated by treatment group)
To determine if OCS-05 treatment is associated within increase of adverse event

Secondary Outcome Measures

Describe the change in Ganglion Cell and Inner Plexiform Layer (GCIPL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6) by treatment group and OCS-05 pooled group
To determine the change in retinal layers thickness as compared to baseline in the affected eye
To describe the change in visual function (high to low contrast visual acuity and Humphrey visual fields) from baseline to each time point (M1, M3, M6) by treatment group and OCS-05 pooled group
Change in clinical vision parameters in the affected eye as compared to baseline
To summarize the Visual Evoked Potential latency and amplitude and the change from baseline of the affected eye to each time point (M3 and M6) by treatment group and OCS-05 pooled group
Change in electrophysiological parameters in the affected eye as compared to baseline
To summarize the EDSS (Expanded Disability Status Scale) scores and the change from baseline to each time point (M1, M3 and M6) by treatment group and OCS-05 pooled group
Change in neurological parameters in the affected eye as compared to baseline
To summarize the incidence of clinically notable laboratory abnormalities
Change in safety laboratory parameters as compared to baseline
To describe the Cmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Characterize the PK profile of OCS-05 3mg/kg
To describe the Tmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Characterize the PK profile of OCS-05 3mg/kg
To describe the AUC0-t of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Characterize the PK profile of OCS-05 3mg/kg

Full Information

First Posted
February 17, 2021
Last Updated
May 9, 2023
Sponsor
Oculis
Collaborators
Neurotrials
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1. Study Identification

Unique Protocol Identification Number
NCT04762017
Brief Title
OCS-05 in Patients With Acute Optic Neuritis
Acronym
ACUITY
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculis
Collaborators
Neurotrials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care
Detailed Description
ACUITY is a phase 2, multicentric, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care. Fourty-two (42) eligible patients aged 18 to 60, with recent onset (visual loss symptoms) of unilateral AON (idiopathic or associated with multiple sclerosis) will be randomized to receive OCS-05 or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis, Optic; Neuritis, With Demyelination
Keywords
Acute Optic Neuritis (AON), Demyelination, Optic Neuritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCS-05
Arm Type
Experimental
Arm Description
Once daily IV infusions of OCS-05 (n=18) for 5 consecutive days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily IV infusions of Placebo (n=18) for 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
OCS-05 IV administration
Intervention Description
Multiple Dose of OCS-05 IV administration for 5 consecutive days
Intervention Type
Other
Intervention Name(s)
Placebo IV administration
Intervention Description
Placebo IV administration for 5 consecutive days
Primary Outcome Measure Information:
Title
Number of patients with treatment-related adverse events (frequencies and percentages tabulated by treatment group)
Description
To determine if OCS-05 treatment is associated within increase of adverse event
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Describe the change in Ganglion Cell and Inner Plexiform Layer (GCIPL) thickness, absolute and relative change from baseline (of the affected eye) to each time point (t5, M1, M3, M6) by treatment group and OCS-05 pooled group
Description
To determine the change in retinal layers thickness as compared to baseline in the affected eye
Time Frame
up to 6 months
Title
To describe the change in visual function (high to low contrast visual acuity and Humphrey visual fields) from baseline to each time point (M1, M3, M6) by treatment group and OCS-05 pooled group
Description
Change in clinical vision parameters in the affected eye as compared to baseline
Time Frame
up to 6 months
Title
To summarize the Visual Evoked Potential latency and amplitude and the change from baseline of the affected eye to each time point (M3 and M6) by treatment group and OCS-05 pooled group
Description
Change in electrophysiological parameters in the affected eye as compared to baseline
Time Frame
Up to 6 months
Title
To summarize the EDSS (Expanded Disability Status Scale) scores and the change from baseline to each time point (M1, M3 and M6) by treatment group and OCS-05 pooled group
Description
Change in neurological parameters in the affected eye as compared to baseline
Time Frame
Up to 6 months
Title
To summarize the incidence of clinically notable laboratory abnormalities
Description
Change in safety laboratory parameters as compared to baseline
Time Frame
Up to 6 months
Title
To describe the Cmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Description
Characterize the PK profile of OCS-05 3mg/kg
Time Frame
Day 1
Title
To describe the Tmax of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Description
Characterize the PK profile of OCS-05 3mg/kg
Time Frame
Day 1
Title
To describe the AUC0-t of OCS-05 for patients having the full PK scheme and for patients having the single PK point at 1.5h post infusion on Day 1
Description
Characterize the PK profile of OCS-05 3mg/kg
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Diagnosed with a unilateral acute optic neuritis with a demyelinating origin Onset of visual loss symptoms in the last 12 days before randomization Main Exclusion Criteria: Optic neuropathy of non-demyelinating origin Known Neuromyelitis optica with autoantibodies against aquaporin-4 (AQP4-Abs) Patients with widespread and symmetric white matter alterations in the screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders) Active, chronic disease (or stable but treated with immune therapy) of the immune system other than Multiple Sclerosis (MS) or Myelin Oligodendrocyte Glycoprotein Antibody associated Disorder (MOGAD)(e.g. Sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency) An alternative cause of visual loss (e.g. compressive or infiltrative lesion of the optic nerve, infections, genetic forms of visual loss. Diagnosed with macular edema, severe myopia (>6 δ) or other disease of the retina at inclusion Known diabetic retinopathy Known glaucoma Female patients of child-bearing potential who are unwilling to use an effective contraception while enrolled on study and for the duration of the study. Male patients not willing to use contraception (abstinence, condom etc..) while enrolled in the study and receiving the experimental drug, and for at least 2 days after the last experimental drug administration. Breastfeeding or pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Acuity Study Team
Phone
+1 617 928 5886
Email
info@oculis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Chang, MD
Organizational Affiliation
Oculis
Official's Role
Study Director
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
CHU - Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Name
CIC Neurosciences - La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Foundation Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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OCS-05 in Patients With Acute Optic Neuritis

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