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

• ClinicalTrials.gov Identifier: NCT05414201
• Recruitment Status: Not yet recruiting
• First Posted: June 10, 2022
• Last Update Posted: June 10, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: June 8, 2022
• First Posted Date: June 10, 2022
• Last Update Posted Date: June 10, 2022
• Estimated Study Start Date: July 4, 2022
• Estimated Primary Completion Date: October 10, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2022)

Percentage of participants that achieve quiescence in both eyes [ Time Frame: Week 30 ]

Quiescence is defined as no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤ 0.5+

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 8, 2022)

• Percentage of participants that achieve no active lesions in both eyes [ Time Frame: Week 30 ]
  Percentage of participants that achieve no active lesions in both eyes.
• Percentage of participants that achieve Anterior Chamber (AC) cell grade ≤ 0.5+ in both eyes [ Time Frame: Week 30 ]
  Slit lamp examinations will be conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam will be used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells.
• Percentage of participants that achieve Vitreous Haze (VH) grade ≤ 0.5+ in both eyes [ Time Frame: Week 30 ]
  Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria: Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured.
• Percentage of participants that achieve no worsening of Best Corrected Visual Acuity (BCVA) by ≥ 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes [ Time Frame: Week 30 ]
  Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA is measured using an ETDRS chart.
• Percentage of participants that achieve a ≥ 50% reduction in immunosuppression load [ Time Frame: Week 30 ]
  Achievement of a ≥ 50% reduction in immunosuppression load
• Percentage of participants that achieve a systemic corticosteriods dose ≤ 7.5 mg [ Time Frame: Week 30 ]
  Achievement of a systemic corticosteriods (CS) dose of ≤ 7.5 mg

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: 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

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Active Non-infectious Intermediate-, Posterior- or Pan-uveitis

Intervention

Drug: Adalimumab

Subcutaneous Injection

Other Name: Humira

Study Arms

Experimental: Adalimumab

Participants will receive a loading dose of Adalimumab 80mg SC at Baseline followed a week later by a dose of Adalimumab 40mg SC every other week.

Intervention: Drug: Adalimumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 8, 2022): 87
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 10, 2023
• Estimated Primary Completion Date: October 10, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05414201
• Other Study ID Numbers: M20-387
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: June 2022