Treatment FOr Corticosteroid Dependent UveitiS

NCT06258915 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: APHP211032
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

FOCUS is the first prospective randomized study comparing standard of care (mycophenolate mofetil) to adalimumab in recently active non infectious uveitis (NIU) with steroid dependency. There is no firm evidence or randomized trials that compared classical immunosuppressive compounds to biological agents; or identified the best treatment in this condition. The burden of NIU has been reduced with the use of immunosuppressive agents and biologics, raising the question of which of these compounds should be preferentially used in recently active NIU with steroid dependency.

Conditions

Non Infectious Uveitis

Keywords

Non-infectious uveitis; Macular oedema; Retinal vascularitis; Adalimumab; Mycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

• Treatment failure rate

  Treatment failure is defined by any of the following in at least one eye: * new active, inflammatory chorioretinal or retinal vascular lesions; * worsening of Best Corrected Visual Acuity (BCVA) by\>3 lines; Score from 20/10 (best vision) to 20/2400 (worst vision). * 2- step increase in anterior chamber cell grade and/or in vitreous haze relative to baseline. Anterior chamber cells scored from 0 (None) to 4+ (intense: fibrin or plastic aquerous) and Vitreous haze Scored from 0 (\<1 cell in field) to +4 (\>100 cells in field) * absence of steroid discontinuation between week 13 and week 19 (as per protocol) * or any additional immunosuppressive drug or injectable steroids

  At week 36

Secondary Outcomes (56)

• Time to treatment failure

  Up to week 55

• Best corrected visual acuity

  At week 4

• Best corrected visual acuity

  At week 8

• Best corrected visual acuity

  At week 12

• Best corrected visual acuity

  At week 16

Study Arms (2)

Adalimumab

EXPERIMENTAL

Drug: Adalimumab

Mycophenolate mofetil

ACTIVE COMPARATOR

Drug: Mycophenolate Mofetil

Interventions

Adalimumab DRUG

Adalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously)

Adalimumab

Mycophenolate Mofetil DRUG

2 g/day orally for 36 weeks

Mycophenolate mofetil

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written, informed consent prior to the performance of any study-specific procedures
• ≥18 years of age
• Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature \[SUN\] criteria) of posterior, or pan- uveitis confirmed by documented medical history
• Active chorioretinal or retinal vascular lesion
• Presence of macular edema by optical coherence.
• ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria)
• ≥ 2+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria)
• Her/his chest X-ray does not show evidence suggestive of active tuberculosis disease
• And there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary tuberculosis disease.
• And these subjects with a latent tuberculosis infection who have not already received a prophylactic tuberculosis treatment must agree in advance to complete such a treatment course.
• For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 3 months and 5 months after stopping therapy for Mycophenolate mofetil (MMF) and adalimumab, respectively, unless sterility is confirmed. The simultaneous use of two complementary methods of contraception is preferable. Methods which may be considered as highly effective methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (according to Clinical Trial Falicitation Group (CTFG) recommendations). Such methods include:
• For Female subjects :
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:
• oral
• intravaginal

You may not qualify if:

• Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted)
• Isolated anterior uveitis
• Monocular patient
• Active tuberculosis
• Positive HIV serology or Hepatitis C Virus (HCV) Hepatitis B Virus (HBV) Ag test
• History of severe allergic or anaphylactic reactions to monoclonal antibodies, mycophenolate mofetil, rifampicin, isoniazid or fluorescein
• History of multiple sclerosis and/or demyelinating disorder
• Hemoglobin \< 8g/dL
• Whole Blood Count (WBC) \< 2.0 x 103/mm3
• Platelet count \< 80 x 103/mm3
• Glomerular filtration rates (GFR) \<30ml/min.
• Transaminases \> 3 times upper normal value
• Use of the following systemic treatments during the specified periods:
• Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Macular Edema

Interventions

Adalimumab; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Central Study Contacts

Bahram BODAGHI, Pr

CONTACT

+33142163728; bahram.bodaghi@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 14, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 14, 2024

Record last verified: 2024-01