A Multicenter, Open-label, Single-arm Study to Demonstrate the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Chinese Subjects Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate-, Posterior-, or Pan-uveitis

  • STATUS
    Recruiting
  • End date
    Oct 10, 2023
  • participants needed
    87
  • sponsor
    AbbVie
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Updated on 18 October 2022
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Summary

Non-infectious intermediate-, posterior- and pan-uveitis (NIIPPU) are sight threatening diseases with a high patient burden and negative impact on quality of life. Corticosteroids remain the mainstay of first-line treatment for NIIPPU in China despite serious side effects associated with long-term and high-dose corticosteroid use. Adalimumab is used to treat NIIPPU in adults who have had inadequate response to corticosteroids, or who need corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. The purpose of this study is to assess adverse events and effectiveness of adalimumab in Chinese participants requiring high dose corticosteroids with NIIPPU.

Adalimumab is a conditionally approved drug in China used to treat participants with NIIPPU. All participants will receive the same treatment. Approximately 87 adult participants will be enrolled at approximately 15 sites in China.

Participants will receive one subcutaneous loading dose of adalimumab at baseline followed a week later by a lower dose of adalimumab every other week for up to 30 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Details
Condition Non-infectious Intermediate Posterior- or Pan-uveitis
Treatment Adalimumab
Clinical Study IdentifierNCT05414201
SponsorAbbVie
Last Modified on18 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female of Chinese descent, with full Chinese parentage
Diagnosed with active non-infectious intermediate uveitis, posterior uveitis, or panuveitis defined by the presence of at least 1 of the following in at least one eye
Active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesion
≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria); or
≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
Receiving oral prednisone from ≥ 10mg/day to ≤ 60mg/day (or oral corticosteroids
equivalent) for at least two weeks before Screening and remaining on the same
dose from Screening to Baseline

Exclusion Criteria

Participants with the following ocular events
Isolated anterior uveitis
Confirmed or suspected infectious uveitis
Ocular masquerade syndromes, such as ocular lymphoma
Presumed ocular histoplasmosis syndrome
Serpiginous choroidopathy
Scleritis
Corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
Macular edema as the only sign of uveitis
Severe VH that precludes visualization of the fundus at the Baseline visit
Intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury
Best Corrected Visual Acuity less than 20 letters (ETDRS) in either eye at the Baseline visit
Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
Neovascular/wet age-related macular degeneration
Abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
Ocular surgery within 90 days prior to the Baseline visit with the exception of refractive laser surgery or retinal laser photocoagulation or YAG (neodymium-doped yttrium aluminium garnet) posterior capsulotomy. These three exceptions are exclusionary within 30 days prior to Baseline
Previous exposure to anti-TNF therapy or any biologic therapy with a potential
therapeutic impact on non-infectious uveitis
Has received glucocorticosteroid implant, Ozurdex® (dexamethasone implant), intravitreal adalimumab, Methotrexate (MTX) or anti-VEGF therapy at any time prior to the Baseline visit
Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit
Participant on cyclophosphamide within 30 days prior to the Baseline visit
Participant has received cyclophosphamide within 30 days prior to the Baseline visit
Participant treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study
Participant received any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of study drug
Participant treated with oral traditional Chinese medicine within 14 day prior to the first dose of study drug
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