A Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Participants Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate, Posterior, or Pan-Uveitis

Last updated: June 21, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

4

Condition

Posterior Uveitis

Uveitis

Treatment

Adalimumab

Clinical Study ID

NCT05414201
M20-387
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female of Chinese descent, with full Chinese parentage.

  • Diagnosed with active non-infectious intermediate uveitis, posterior uveitis, orpanuveitis defined by the presence of at least 1 of the following in at least oneeye:

  • 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 corticosteroidsequivalent) for at least two weeks before Screening and remaining on the same dosefrom Screening to Baseline.

Exclusion

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 thatlikely 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 evidenceof glaucomatous optic nerve injury;

  • Best Corrected Visual Acuity less than 20 letters Early Treatment DiabeticRetinopathy Study (ETDRS) in either eye at the Baseline visit;

  • Proliferative or severe non-proliferative diabetic retinopathy or clinicallysignificant 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 damageindependent of the inflammatory process.

  • Ocular surgery within 90 days prior to the Baseline visit with the exception ofrefractive laser surgery or retinal laser photocoagulation or YAG (neodymium-doped yttrium aluminium garnet) posterior capsulotomy. These threeexceptions are exclusionary within 30 days prior to Baseline.

  • Previous exposure to anti-a TNF therapy inhibitor or any biologic therapy with apotential therapeutic impact on non-infectious uveitis and discontinued for reasonsother than lack of efficacy or intolerance (e.g., change of insurance) is allowedafter completing the specified wash-out period prior to the Baseline visit.Participants who have had lack of efficacy or intolerance to TNF inhibitors (including Humira and its biosimilars) are not eligible.

  • Has received glucocorticosteroid implant, Ozurdex® (dexamethasone implant), orintravitreal adalimumab, Methotrexate (MTX) or anti-VEGF therapy at any time priorto the Baseline visit. For those with previous exposure of anti-VEGF therapy,participants must complete the specified wash-out period prior to the baselinevisit.

  • Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30days prior to the baseline visit or oral anti-infectives within 14 days prior to theBaseline visit.

  • Participant has been receiving cyclophosphamide within 30 days and initiated newcyclophosphamide treatment within 30 days prior to the Baseline visit.

  • Participant treated with any investigational drug within 30 days or 5 half-lives ofthe drug (whichever is longer) prior to the first dose of study drug or is currentlyenrolled in another clinical study.

  • Participant received any live vaccine with replicating potential within 28 daysprior to the first dose of study drug, or expected need of live vaccination with anylive vaccine with replicating potential during study participation including atleast 70 days after the last dose of study drug. Live vaccines that are incapable ofreplicating (e.g., JYNNEOS monkeypox vaccine or Convidecia or Convidecia AirCOVID-19 vaccines) are permitted.

  • Participant treated with oral traditional Chinese medicine (described for thetreatment of UV) within 14 day prior to the first dose of study drug.

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: Adalimumab
Phase: 4
Study Start date:
July 07, 2022
Estimated Completion Date:
June 10, 2024

Connect with a study center

  • Peking University First Hospital /ID# 243055

    Beijing, Beijing 100034
    China

    Site Not Available

  • Shanghai General hospital /ID# 247252

    Shanghai, Shanghai 200080
    China

    Site Not Available

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 247251

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • The second affiliated hospital of Zhejiang University school of medicine /ID# 247251

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Eye hospital,WMU Zhejiang Eye Hospital /ID# 247253

    Wenzhou, Zhejiang 325612
    China

    Site Not Available

  • Beijing Tongren Hospital, CMU /ID# 243054

    Beijing, 100730
    China

    Site Not Available

  • The first affiliated hospital of chongqing medical university /ID# 242971

    Chongqing, 400016
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital /ID# 243056

    Tianjin, 300384
    China

    Site Not Available

  • Xi'an people's hospital/Xi'an fourth hospital /ID# 243371

    XI An, 710000
    China

    Site Not Available

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