Uveitis Posterior Non-InfectiousPhase 2OPTYK-1NCT05953688
POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
A Phase 2 study testing ESK-001 in people with Uveitis Posterior Non-Infectious and Uveitis, Intermediate, run by Alumis Inc at 17 sites in United States.
Trial summary
This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Uveitis Posterior Non-Infectious, Uveitis, Intermediate, Noninfectious Panuveitis
- What is being tested?
- ESK-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 17 sitesUnited States
- Study dates
- 14 Jun 2023to 13 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide consent
- Male and females, age 18 to 70 years
- Diagnosis of active noninfectious intermediate, posterior or panuveitis
- Must have active uveitis at Screening in at least one eye as defined by:
- Active inflammatory chorioretinal and/or inflammatory retinal vascular lesion or lesions, or
- ≥ 2+ VH in accordance with the NEI/SUN criteria
- Males and females must use highly effective methods of contraception for the entirety of the study
Who cannot join
- Diagnosis of infectious uveitis
- Has elevated intraocular pressures or severe glaucoma
- Positive for HIV, Hepatitis B or C or active or inadequately latent tuberculosis at screening
- Positive for syphilis at screening
- Patients with QTcF >450 msec (both males and females) at screening
- Known active malignancy or history of malignancy within the past 5 years
Show all 10Show fewer
- History of chronic drug or alcohol abuse
- Live vaccines
- No planned ocular or any other surgery during the course of the study
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Investigator Site#1075
Bellaire, Texas, 77401
Investigator Site#1065
Beverly Hills, California, 90211
Investigator Site #1083
Durham, North Carolina, 27705
Investigator Site #1064
Erie, Pennsylvania, 16507
Investigator Site #1085
Hagerstown, Maryland, 21740
Investigator Site #1074
Katy, Texas, 77494
Investigator Site#1068
Lakewood, Colorado, 80228
Investigator Site #1073
Los Angeles, California, 90033
Investigator Site #1072
Los Angeles, California, 90095
Investigator Site#1066
Nashville, Tennessee, 37203
Investigator Site #1084
Nashville, Tennessee, 37232
Investigator Site #1086
Oak Park, Illinois, 60304
Investigator Site #1076
Palisades Park, New Jersey, 07650
Investigator Site #1080
Palo Alto, California, 94303
Investigator Site #1078
Plano, Texas, 75075
Investigator Site #1079
Sacramento, California, 95825
Investigator Site #1069
Waltham, Massachusetts, 02451
About this study
Official title: A Proof-of-Concept, Randomized, Double-Masked Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Noninfectious Intermediate, Posterior, or Panuveitis (OPTYK-1)
This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.
Read the detailed description
This study will consist of a 2-week screening period (+7 days), 24-week treatment period, followed by a 24-week extension period, and a 4-week follow up period for a total of up to 55 weeks. Each participant will be randomized to receive one of two doses of ESK-001 daily for 24 weeks. Participants that do not meet the treatment failure criteria at Week 24 will continue into the extension period.
- Being tested
- ESK-001
- Medical subject headings
- Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESK-001Drug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| ESK-001 Dose Level 1 | Experimental | ESK-001 administered as an oral tablet Receives: Drug: ESK-001 |
| ESK-001 Dose Level 2 | Experimental | ESK-001 administered as an oral tablet Receives: Drug: ESK-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the proportion of patients failing treatment by Week 24
The proportion of patients failing treatment for active NIU by Week 24 between 2 ESK-001 treatment groups. Treatment failure is defined as a patient meeting at least 1 of the treatment failure criteria in at least 1 eye at Week 24.
Measured: 24 Weeks
Secondary outcomes (4)
To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the time to treatment failure on or after Week 24
Time to treatment failure on or after Week 24 between 2 ESK-001 treatment groups. Time to treatment failure is defined as time to the visit of the first treatment failure as defined per protocol. Median time to treatment failure in each treatment group will be reported and compared.
Measured: 24 Weeks
To assess the safety and tolerability of ESK-001 in patients with active NIU by comparing the incidence and proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Clinical and laboratory assessments including blood tests, ECGs, hematological measures and physical examinations throughout the study. The number and proportion of TEAEs, SAEs, AEs leading to study discontinuation, and AEs of greater than grade 3 severity will recorded per treatment group and across all groups.
Measured: Through study completion, up to 52 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)
Plasma concentrations and PK parameters including steady-state maximum observed concentration (Cmax) for ESK-001 at Day 1, Week 24, and Week 48.
Measured: Through study completion, up to 48 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough)
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 at Week 24, and Week 48.
Measured: Through study completion, up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start14 Jun 2023
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Why it stopped: Terminated based on interim efficacy data that did not meet the Sponsor's criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis Posterior Non-InfectiousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alumis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953688
- Sponsor's protocol ID
- ESK-001-014
- Acronym
- OPTYK-1
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept, Randomized, Double-Masked Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Noninfectious Intermediate, Posterior, or Panuveitis (OPTYK-1)
- ClinicalTrials.gov ID
- NCT05953688
- Acronym / sponsor ID
- OPTYK-1 / ESK-001-014
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated based on interim efficacy data that did not meet the Sponsor's criteria.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alumis IncIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.
Detailed description
This study will consist of a 2-week screening period (+7 days), 24-week treatment period, followed by a 24-week extension period, and a 4-week follow up period for a total of up to 55 weeks. Each participant will be randomized to receive one of two doses of ESK-001 daily for 24 weeks. Participants that do not meet the treatment failure criteria at Week 24 will continue into the extension period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESK-001 Dose Level 1 | Experimental | Drug: ESK-001ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 2 | Experimental | Drug: ESK-001ESK-001 administered as an oral tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to provide consent
- Male and females, age 18 to 70 years
- Diagnosis of active noninfectious intermediate, posterior or panuveitis
- Must have active uveitis at Screening in at least one eye as defined by:
- Males and females must use highly effective methods of contraception for the entirety of the study
Key exclusion criteria (10 listed)
- Diagnosis of infectious uveitis
- Has elevated intraocular pressures or severe glaucoma
- Positive for HIV, Hepatitis B or C or active or inadequately latent tuberculosis at screening
- Positive for syphilis at screening
- Patients with QTcF >450 msec (both males and females) at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESK-001Oral tablet | Drug | ESK-001 Dose Level 1, ESK-001 Dose Level 2 |
Primary outcome
To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the proportion of patients failing treatment by Week 24
Time frame: 24 Weeks
The proportion of patients failing treatment for active NIU by Week 24 between 2 ESK-001 treatment groups. Treatment failure is defined as a patient meeting at least 1 of the treatment failure criteria in at least 1 eye at Week 24.
4 secondary outcomes
To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the time to treatment failure on or after Week 24
Time frame: 24 Weeks
To assess the safety and tolerability of ESK-001 in patients with active NIU by comparing the incidence and proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: Through study completion, up to 52 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)
Time frame: Through study completion, up to 48 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough)
Time frame: Through study completion, up to 48 weeks
Results and safety
The study was stopped early (reason given: Terminated based on interim efficacy data that did not meet the Sponsor's criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Uveitis Posterior Non-Infectious
Not yet recruiting
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis
RecruitingPhase 1
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
Non Infectious Uveitis
Not yet recruitingPhase 2
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Noninfectious Intermediate, Posterior, or Panuveitis
Not yet recruitingObservational study
Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
Noninfectious Posterior Uveitis, Uveitis, Posterior
Active, not recruitingPhase 3
A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis
Uveitis, Posterior, Uveitis, Intermediate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESK-001 in people with Uveitis Posterior Non-Infectious and Uveitis, Intermediate, run by Alumis Inc at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated based on interim efficacy data that did not meet the Sponsor's criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the proportion of patients failing treatment by Week 24 (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.