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UveitisPhase 2LINNAEANCT04706741

A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis

A Phase 2 study testing Izokibep and Prednisone/Prednisolone in people with Uveitis, run by ACELYRIN Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, phase 2 trial to explore the efficacy and safety of Izokibep (ABY-035) in treating disease activity in patients with non-Infectious Intermediate, Posterior, Pan-Uveitis with significant disease activity at BL despite treatment with stable doses of corticosteroids (≥7 to ≤40 mg/day oral… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Uveitis
What is being tested?
Izokibep and Prednisone/Prednisolone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
4 sitesUnited States
Study dates
6 Jan 2022to 14 Nov 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age at SCR
  • Previously documented medical history with diagnosed unilateral or bilateral NIIPPU
  • Active disease at BL defined by the presence of at least 1 of the following criteria in at least one eye despite treatment with stable doses of corticosteroids for at least 2 weeks:
  • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by Dilated Indirect Ophthalmoscopy (DIO), Fundus Photography, Fluorescein angiography (FA), spectral-domain optical coherence tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reader's assessment using FA, FP, and or SD-OCT is required to confirm eligibility).
  • ≥2+ vitreous haze ( NEI/SUN criteria) by DIO and Fundus Photography (the central reader's assessment using Fundus Photography is required to confirm eligibility).
  • On treatment with oral corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent) at a stable dose for at least 2 weeks before BL

Who cannot join

  • Subject with isolated anterior uveitis
  • Subject with Occlusive Behçet's disease, Acute Posterior Multifocal Placoid Pigment Epitheliopathy, Acute Posterior Pigment Epithelitis, Multiple Evanescent White Dot Syndrome, Punctate Inner Choroiditis or serpiginous choroidopathy
  • Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, syphilis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 infection, Whipple's disease, herpes zoster virus, and herpes simplex virus
  • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
  • Planned (elective) eye surgery within 80 weeks after BL
  • History of prior refractive laser surgery, retinal laser photocoagulation, or neodymium-doped yttrium aluminium garnet posterior capsulotomy within 30 days before BL
Show all 31Show fewer
  • History of any other prior ocular surgery within 90 days before BL
  • Subject with intraocular pressure (IOP) of ≥25 mmHg while on ≥2 glaucoma medications or evidence of glaucomatous optic nerve injury
  • Subject with severe vitreous haze that precludes visualization of the fundus at BL
  • Subject has a contraindication for mydriatic eye drops OR subject cannot be dilatated sufficiently well to permit good fundus visualization
  • Subject with BCVA <20 letters (ETDRS) in at least one eye at BL
  • Subject with intermediate uveitis or panuveitis who has presence or history of whitish exudates on the inferior pars plana (snowbanking) or vitreal inflammatory aggregates (snowballs) in combination with a medical history or signs or symptoms suggestive of a demyelinating disease such as multiple sclerosis
  • Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
  • Subject with neovascular/wet age-related macular degeneration
  • Subject with an abnormality of the vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
  • Subject with a history of active scleritis within 12 months of SCR Criteria that relate to comorbidity
  • Uncontrolled inflammatory bowel disease
  • Infection requiring treatment with IV anti-infectives within 30 days before BL or oral anti-infectives within 14 days before BL
  • Subject with any active infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the trial
  • History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 3 years (except for basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence) Criteria that relate to laboratory testing
  • A positive test for subclinical/latent TB infection (i.e. positive QuantiFERON®-TB Gold test or equivalent product) suggestive of TB at SCR will require that the subject is thoroughly evaluated for active tuberculosis. If the subject is diagnosed with latent TB and active TB can be ruled out, the subject can be included if the subject has gone through an adequate course of prophylaxis as per local standard of care 12 weeks prior to SCR.
  • Positive Fluorescent treponemal (FTA)- absorption test (syphilis)
  • Subject with intolerance to high-dose oral corticosteroids (equivalent to oral prednisolon 1 mg/kg/day or 60 mg/day)
  • The subject has received any biologic therapy (including ABY-035 or any other IL-17i or IL-17 receptor inhibitor, e.g. secukinumab, ixekizumab, brodalumab or anti-TNF-alpha therapy) within 8 weeks before BL.
  • Subject on >1 concomitant non-biologic NCSIT
  • Subject on 1 concomitant non-biologic NCSIT:
  • But the medication is not listed as permissible b) The medication is listed as permissible, but the dose has not been stable within the last 3 months before BL c) The medication is listed as permissible, but the dose exceeds the allowable level; to be acceptable, the dose needs to be: i) Methotrexate (MTX) ≤25 mg/week ii) CsA ≤4 mg/kg/day iii) Mycophenolate mofetil ≤2 grams/day or an equivalent drug to mycophenolate mofetil (e.g., mycophenolic acid) at an equivalent dose approved by the Medical monitor iv) Azathioprine ≤175 mg/day v) Tacrolimus (oral formulation) ≤8 mg/day
  • 28] The subject has received Retisert®, Iluvien®, or Yutiq® (glucocorticosteroids implant) within 3 years before BL or who has had complications related to the device. The subject has had any of these glucocorticosteroids implant (glucocorticosteroid implant) removed within 90 days before BL or has had complications related to the removal of the device 29] The subject has received intraocular or periocular corticosteroids within 90 days before BL 30] The subject has received Ozurdex® (dexamethasone implant) within 6 months before BL 31] The subject has received intravitreal methotrexate within 90 days before BL 32] The subject has received intravitreal anti- Vascular Endothelial Growth Factor (VEGF) therapy:
  • within 45 days of BL for Lucentis® (ranibizumab) or Avastin® (bevacizumab)
  • or within 60 days of BL for anti-VEGF Trap (aflibercept)
  • or within 84 days of BL for Beovu® (brolucizumab) 33] Subject on systemic carbonic anhydrase inhibitor within 1 week before SCR 34] Subject on cyclophosphamide within 30 days before BL 35] Prior or current use of chlorambucil

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Research Site

    Hagerstown, Maryland, 21740

  • Research Site

    Los Angeles, California, 90211

  • Research Site

    Palo Alto, California, 94303

  • Research Site

    Plano, Texas, 75075

Other trials in United States

About this study

Official title: A Phase 2 Trial of the Efficacy and Safety of the Interleukin-17A Inhibitor Izokibep (ABY-035) in the Treatment of Non-infectious Intermediate, Posterior or Pan-uveitis (LINNAEA)

This is a multicenter, phase 2 trial to explore the efficacy and safety of Izokibep (ABY-035) in treating disease activity in patients with non-Infectious Intermediate, Posterior, Pan-Uveitis with significant disease activity at BL despite treatment with stable doses of corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent).

Read the detailed description

This is a multicenter, phase 2 trial to explore the efficacy and safety of Izokibep (ABY-035) in treating disease activity in patients with non-Infectious Intermediate, Posterior, Pan-Uveitis with significant disease activity at BL despite treatment with stable doses of corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent).

Conditions
Uveitis
Being tested
Izokibep, Prednisone/Prednisolone
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IzokibepDrug

    Also called ABY-035

    Izokibep is an Interleukin-17 Inhibitor that will be administered subcutaneously

  • Prednisone/PrednisoloneDrug

    Also called Prednisone

    Background Corticosteroid

Study groups in NCT04706741
Study groupRoleWhat they receive
Izokibep and maintenance corticosteroid doseExperimentalIzokibep+ Prednisolon/Prednisone
Receives: Drug: Izokibep; Drug: Prednisone/Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response

    Complete Response is defined as Yes/No by visit by meeting at least 1 of the following criteria in at least one eye:

    1. Inflammatory, chorioretinal and/or inflammatory retinal vascular lesions - No such active lesions; all prior lesions appear inactive
    2. ACC Count - Trace or absent (0.5+ or 0)
    3. Vitreous Haze - Trace or absent (0.5+ or 0)

    Measured: BL to Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start6 Jan 2022
  3. Primary completion25 Aug 2022
  4. Study completion14 Nov 2022

Resources

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
Not applicable
Intervention model
Single group
Model description
The primary purpose of the study is treatment of active Noninfectious Intermediate, Posterior or Pan-uveitis The study includes one treatment arm, into which 10 patients are planned to be enrolled
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706741
Sponsor's protocol ID
ABY-035-203
Acronym
LINNAEA
Status last verified
Aug 2023
First submitted
11 Jan 2021
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Izokibep and Prednisone/Prednisolone in people with Uveitis, run by ACELYRIN Inc. at 4 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 6 inclusion and 31 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: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Complete Response (time frame: BL to Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706741.

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 12 Feb 2024.

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