Non Infectious UveitisPhase 3FOCUSNCT06258915
Treatment FOr Corticosteroid Dependent UveitiS
A Phase 3 study testing Adalimumab and Mycophenolate Mofetil in people with Non Infectious Uveitis, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non Infectious Uveitis
- What is being tested?
- Adalimumab and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Recent activity of Non Infectious Uveitis as defined by the presence of at least 1 of the following parameters in either eye within the 3 months prior to inclusion visit despite >7mg/day of oral prednisone:
- Active chorioretinal or retinal vascular lesion
- Presence of macular edema by optical coherence.
Show all 34Show fewer
- ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)
- ≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
- Chest X-ray (postero-anterior and lateral) or CT-scanner results within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
- A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) at inclusion is eligible if:
- 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 female subjects of child-bearing potential: a negative pregnancy test at inclusion
- 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
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).
- For male subjects :
- use of condoms
- vasectomy (with documentation of azoospermia)
- sexual abstinence
- Affiliated to a social security system
Who cannot join
- 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 malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix, non-metastatic squamous or basal cell carcinoma of the skin.
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- History of severe allergic or anaphylactic reactions to monoclonal antibodies, mycophenolate mofetil, rifampicin, isoniazid or fluorescein
- Infection requiring treatment with intravenous antibiotics within 3 weeks prior to inclusion
- History of multiple sclerosis and/or demyelinating disorder
- Laboratory values assessed during inclusion:
- 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:
- Treatment with any systemic alkylating agents within 12 months prior to inclusion (e.g., cyclophosphamide, chlorambucil)
- Any live (attenuated) vaccine within 4 weeks prior to inclusion.
- Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
- Pregnancy or breastfeeding
- Under legal protection
- Participation in another interventional study involving human participants or in the exclusion period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Multicenter Study Comparing Efficacy and Safety of Adalimumab to That of Mycophenolate Mofetil in Steroid Dependent Non-infectious Uveitis
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
- Being tested
- Adalimumab, Mycophenolate Mofetil
- Keywords
- Non-infectious uveitis, Macular oedema, Retinal vascularitis, Adalimumab, Mycophenolate mofetil
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Adalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously)
2 g/day orally for 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Not described Receives: Drug: Adalimumab |
| Mycophenolate mofetil | Active comparator | Not described Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At week 36
Secondary outcomes (56)
Time to treatment failure
Measured: Up to week 55
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 4
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 8
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 12
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 16
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 20
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 24
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 30
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 36
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Measured: At week 55
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 4
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 8
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 12
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 16
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 20
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 24
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 30
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 36
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Measured: At week 55
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 4
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 8
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 12
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 16
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 20
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 24
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 30
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 36
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Measured: At week 55
Central retinal thickness in each eye from baseline
Measured: At week 4
Central retinal thickness in each eye from baseline
Measured: At week 8
Central retinal thickness in each eye from baseline
Measured: At week 12
Central retinal thickness in each eye from baseline
Measured: At week 16
Central retinal thickness in each eye from baseline
Measured: At week 20
Central retinal thickness in each eye from baseline
Measured: At week 24
Central retinal thickness in each eye from baseline
Measured: At week 30
Central retinal thickness in each eye from baseline
Measured: At week 36
Central retinal thickness in each eye from baseline
Measured: At week 55
Proportion of patients with central macular thickness< 300 microns
Measured: At week 4
Proportion of patients with central macular thickness< 300 microns
Measured: At week 8
Proportion of patients with central macular thickness< 300 microns
Measured: At week 12
Proportion of patients with central macular thickness< 300 microns
Measured: At week 16
Proportion of patients with central macular thickness< 300 microns
Measured: At week 20
Proportion of patients with central macular thickness< 300 microns
Measured: At week 24
Proportion of patients with central macular thickness< 300 microns
Measured: At week 30
Proportion of patients with central macular thickness< 300 microns
Measured: At week 36
Proportion of patients with central macular thickness< 300 microns
Measured: At week 55
Time to optical coherence tomographic (OCT) evidence of macular edema in at least one eye
Measured: Up to week 55
National Eye Institute Visual Functioning Questionaire-25 (VFQ-25) composite score
Note after responses converted: 100=Best, 0=Worst possible score
Measured: At week 12
National Eye Institute Visual Functioning Questionaire-25 (VFQ-25) composite score
Note after responses converted: 100=Best, 0=Worst possible score
Measured: At week 24
National Eye Institute Visual Functioning Questionaire-25 (VFQ-25) composite score
Note after responses converted: 100=Best, 0=Worst possible score
Measured: At week 36
Measures of corticosteroid sparing
Percent meeting targets [<0.1 mg/kg/day prednisone], mean change, mean dose at week 55, and cumulative dose
Measured: Up to week 55
Cumulative incidence of relapse
Measured: Up to week 55
Number of relapses
Measured: Up to week 55
Number of clinical manifestations of underlying disease
Depending on the underlying disease
Measured: Up to week 55
Frequency and severity of adverse events
Measured: Up to week 55
Treatment discontinuation
Measured: Up to week 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Infectious UveitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258915
- Sponsor's protocol ID
- APHP211032
- Acronym
- FOCUS
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicenter Study Comparing Efficacy and Safety of Adalimumab to That of Mycophenolate Mofetil in Steroid Dependent Non-infectious Uveitis
- ClinicalTrials.gov ID
- NCT06258915
- Acronym / sponsor ID
- FOCUS / APHP211032
- Conditions
- Non Infectious Uveitis
- Keywords
- Non-infectious uveitis, Macular oedema, Retinal vascularitis, Adalimumab, Mycophenolate mofetil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: Adalimumab |
| Mycophenolate mofetil | Active comparator | Drug: Mycophenolate Mofetil |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 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
- Recent activity of Non Infectious Uveitis as defined by the presence of at least 1 of the following parameters in either eye within the 3 months prior to inclusion visit despite >7mg/day of oral prednisone:
- Chest X-ray (postero-anterior and lateral) or CT-scanner results within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAdalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously) | Drug | Adalimumab |
| Mycophenolate Mofetil2 g/day orally for 36 weeks | Drug | Mycophenolate mofetil |
Primary outcome
Treatment failure rate
Time frame: At week 36
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
56 secondary outcomes
Time to treatment failure
Time frame: Up to week 55
Best corrected visual acuity
Time frame: At week 4
Best corrected visual acuity
Time frame: At week 8
Best corrected visual acuity
Time frame: At week 12
Best corrected visual acuity
Time frame: At week 16
Best corrected visual acuity
Time frame: At week 20
Best corrected visual acuity
Time frame: At week 24
Best corrected visual acuity
Time frame: At week 30
Best corrected visual acuity
Time frame: At week 36
Best corrected visual acuity
Time frame: At week 55
Anterior chamber cell grade in each eye
Time frame: At week 4
Anterior chamber cell grade in each eye
Time frame: At week 8
Anterior chamber cell grade in each eye
Time frame: At week 12
Anterior chamber cell grade in each eye
Time frame: At week 16
Anterior chamber cell grade in each eye
Time frame: At week 20
Anterior chamber cell grade in each eye
Time frame: At week 24
Anterior chamber cell grade in each eye
Time frame: At week 30
Anterior chamber cell grade in each eye
Time frame: At week 36
Anterior chamber cell grade in each eye
Time frame: At week 55
Vitreous haze grade in each eye.
Time frame: At week 4
Vitreous haze grade in each eye.
Time frame: At week 8
Vitreous haze grade in each eye.
Time frame: At week 12
Vitreous haze grade in each eye.
Time frame: At week 16
Vitreous haze grade in each eye.
Time frame: At week 20
Vitreous haze grade in each eye.
Time frame: At week 24
Vitreous haze grade in each eye.
Time frame: At week 30
Vitreous haze grade in each eye.
Time frame: At week 36
Vitreous haze grade in each eye.
Time frame: At week 55
Central retinal thickness in each eye from baseline
Time frame: At week 4
Central retinal thickness in each eye from baseline
Time frame: At week 8
Central retinal thickness in each eye from baseline
Time frame: At week 12
Central retinal thickness in each eye from baseline
Time frame: At week 16
Central retinal thickness in each eye from baseline
Time frame: At week 20
Central retinal thickness in each eye from baseline
Time frame: At week 24
Central retinal thickness in each eye from baseline
Time frame: At week 30
Central retinal thickness in each eye from baseline
Time frame: At week 36
Central retinal thickness in each eye from baseline
Time frame: At week 55
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 4
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 8
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab and Mycophenolate Mofetil in people with Non Infectious Uveitis, run by Assistance Publique - Hôpitaux de Paris.
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 34 inclusion and 22 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: opening soon, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahram BODAGHI, Pr (+33142163728, bahram.bodaghi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate (time frame: At week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.