Non-infectious Intermediate Posterior- or Pan-uveitisPhase 4NCT05414201
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
A Phase 4 study testing Adalimumab in people with Non-infectious Intermediate Posterior- or Pan-uveitis, run by AbbVie at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infectious Intermediate Posterior- or Pan-uveitis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 7 sitesChina
- Study dates
- 7 Jul 2022to 10 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 23Show fewer
- 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 Early Treatment Diabetic Retinopathy Study (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-a TNF therapy inhibitor or any biologic therapy with a potential therapeutic impact on non-infectious uveitis and discontinued for reasons other than lack of efficacy or intolerance (e.g., change of insurance) is allowed after 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), or intravitreal adalimumab, Methotrexate (MTX) or anti-VEGF therapy at any time prior to the Baseline visit. For those with previous exposure of anti-VEGF therapy, participants must complete the specified wash-out period prior to the baseline visit.
- Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the Baseline visit.
- Participant has been receiving cyclophosphamide within 30 days and initiated new cyclophosphamide treatment 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 with replicating potential within 28 days prior to the first dose of study drug, or expected need of live vaccination with any live vaccine with replicating potential during study participation including at least 70 days after the last dose of study drug. Live vaccines that are incapable of replicating (e.g., JYNNEOS monkeypox vaccine or Convidecia or Convidecia Air COVID-19 vaccines) are permitted.
- Participant treated with oral traditional Chinese medicine (described for the treatment of UV) within 14 day prior to the first dose of study drug.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University First Hospital /ID# 243055
Beijing, Beijing Municipality, 100034
Beijing Tongren Hospital, CMU /ID# 243054
Beijing, 100730
The second affiliated hospital of Zhejiang University school of medicine /ID# 247251
Hangzhou, Zhejiang, 310009
Shanghai General hospital /ID# 247252
Shanghai, Shanghai Municipality, 200080
Tianjin Medical University Eye Hospital /ID# 243056
Tianjin, 300384
Eye hospital,WMU Zhejiang Eye Hospital /ID# 247253
Wenzhou, Zhejiang, 325612
Xi'an people's hospital/Xi'an fourth hospital /ID# 243371
Xi'an, 710000
About this study
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
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.
Read more
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.
- Being tested
- Adalimumab
- Keywords
- Humira, Adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | 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. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants that achieve quiescence in both eyes
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+
Measured: Week 30
Secondary outcomes (6)
Percentage of participants that achieve no active lesions in both eyes
Percentage of participants that achieve no active lesions in both eyes.
Measured: Week 30
Percentage of participants that achieve Anterior Chamber (AC) cell grade ≤ 0.5+ in both eyes
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.
Measured: Week 30
Percentage of participants that achieve Vitreous Haze (VH) grade ≤ 0.5+ in both eyes
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.
Measured: Week 30
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
Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA is measured using an ETDRS chart.
Measured: Week 30
Percentage of participants that achieve a ≥ 50% reduction in immunosuppression load
Achievement of a ≥ 50% reduction in immunosuppression load
Measured: Week 30
Percentage of participants that achieve a systemic corticosteriods dose ≤ 7.5 mg
Achievement of a systemic corticosteriods (CS) dose of ≤ 7.5 mg
Measured: Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start7 Jul 2022
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious Intermediate Posterior- or Pan-uveitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414201
- Sponsor's protocol ID
- M20-387
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05414201
- Acronym / sponsor ID
- M20-387
- Keywords
- Humira, Adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 10 Jun 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: AdalimumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (23 listed)
- Participants with the following ocular events:
- Previous exposure to anti-a TNF therapy inhibitor or any biologic therapy with a potential therapeutic impact on non-infectious uveitis and discontinued for reasons other than lack of efficacy or intolerance (e.g., change of insurance) is allowed after 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), or intravitreal adalimumab, Methotrexate (MTX) or anti-VEGF therapy at any time prior to the Baseline visit. For those with previous exposure of anti-VEGF therapy, participants must complete the specified wash-out period prior to the baseline visit.
- Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the Baseline visit.
- Participant has been receiving cyclophosphamide within 30 days and initiated new cyclophosphamide treatment within 30 days prior to the Baseline visit.
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 |
|---|---|---|
| AdalimumabAlso: HumiraSubcutaneous Injection | Drug | Adalimumab |
Primary outcome
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+
6 secondary outcomes
Percentage of participants that achieve no active lesions in both eyes
Time frame: Week 30
Percentage of participants that achieve Anterior Chamber (AC) cell grade ≤ 0.5+ in both eyes
Time frame: Week 30
Percentage of participants that achieve Vitreous Haze (VH) grade ≤ 0.5+ in both eyes
Time frame: Week 30
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
Percentage of participants that achieve a ≥ 50% reduction in immunosuppression load
Time frame: Week 30
Percentage of participants that achieve a systemic corticosteriods dose ≤ 7.5 mg
Time frame: Week 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Yes. 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.
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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab in people with Non-infectious Intermediate Posterior- or Pan-uveitis, run by AbbVie at 7 sites in China.
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 6 inclusion and 23 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: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants that achieve quiescence in both eyes (time frame: Week 30). 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 10 Jun 2025.