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UveitisPhase 4NCT05180526

Assessment of Safety , Clinical Efficacy With QLETLI in Non-infectious Uveitis (UV)

A Phase 4 study testing QLETLI in people with Uveitis, run by Bio-Thera Solutions at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled. Screening period (-2~0 weeks) ,Treatment period (1-22 weeks), Follow-up period, At the same time, plasma concentration will be determined Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Uveitis
What is being tested?
QLETLI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
7 sitesChina
Study dates
27 Dec 2021to 5 Aug 2025
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients voluntarily participated in the study and signed informed consent
  • Aged between 18 and 70 (including threshold), male or female;
  • Diagnosis of non-infectious intermediate, posterior, or total uveitis in at least one eye;
  • Received maintenance therapy (oral prednisone 10-60mg/day or equivalent glucocorticoid for ≧2 weeks before screening, and no dose adjustment from screening to baseline;
  • At baseline, at least one eye was diagnosed with active uveitis, presenting as meeting at least one of the following criteria: active inflammatory chorioretinal and/or inflammatory retinal vasculopathy; Cell grade of anterior chamber ≧2+; Degree of vitreous turbid ≧2+;
  • Negative serum pregnancy test results of women of childbearing age during screening visits;

Who cannot join

  • Patients with the following eye conditions:
  • Patients with simple anterior uveitis;
  • Uveitis with macular edema as the only manifestation;
  • is confirmed or suspected infectious uveitis (including but not limited to the following causes of infectious uveitis, tuberculosis, cytomegalovirus, lyme disease, toxoplasmosis, human, T, Whipple's disease virus type 1 infection, herpes zoster virus and herpes simplex virus) or disguise syndrome (for example: eye trauma, lymphoma, malignant tumor, or surgery, etc.);
  • Uncontrolled glaucoma, defined as intraocular pressure higher than 25 mmHg after drug treatment, or optic nerve damage;
  • Best corrected visual acuity of less than 20 letters in at least one eye at baseline;
Show all 31Show fewer
  • With other fundus diseases (such as fertile or serious non fertile diabetic retinopathy or diabetic retinopathy with clinical significance of macular edema, retinal vein occlusion, macular degeneration, age, sex, blood vessel patterns change, the pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease, etc.);
  • Demyelinating disease (including myelitis and optic neuritis) or a history of neurology suggesting symptoms of demyelinating disease (including but not limited to optic neuritis);
  • Refractive media opacity or pupil failure that significantly interferes with visual acuity detection, anterior segment and fundus assessment;
  • One-eyed patients deemed unsuitable for inclusion by the investigator;
  • Peribulbar, intravitreal or subocular corticosteroid injections were given within 30 days prior to screening;
  • Posterior capsulotomy was performed within 30 days prior to screening;
  • Cataract surgery is expected within 90 days prior to screening or during the study period;
  • An intravitreal injection of anti-VEGF therapy (e.g., raizumab, apecivir, or Combocept) within 90 days prior to baseline;
  • Ozurdex implants (dexamethasone implants) were performed within 6 months prior to baseline;
  • Treatment with intravitreal injection of methotrexate within 90 days prior to baseline;
  • Had been treated with vitreous Retisert (glucocorticoid implant) or had complications with the implant during the 36 months prior to baseline; Removal of Retisert within 90 days prior to baseline or complications of removal.
  • Having any of the following general conditions:
  • Subjects meet any of the following criteria associated with latent or active tuberculosis (TB) infection:
  • . A history of active TB ≤ 3 years before screening (but can also be included if it is > 3 years and documented completion of adequate treatment); B. Signs or symptoms suggestive of active TB at the time of screening in the history and/or physical examination; C. Recent close contact with someone with active TB; D. If a TB infection T-cell test is positive at the time of screening, subjects will be excluded from the study if their first TB infection T-cell test is inconclusive. For suitable standards has been completed before screening latent TB treatment and no other risk factors, imaging findings, or support the latent or signs of active TB specific subjects, for positive or uncertain results may be the exception handling, researchers with the qualified physician judgment, tuberculosis (including extrapulmonary) risk, decision and discuss with bidders;
  • Positive hepatitis C antibody during screening; Or HIV antibody positive; Or treponema pallidum antibody positive;
  • Symptoms of severe, progressive or uncontrollable kidney, liver, blood, gastrointestinal, lung, cardiovascular, neurological or brain disease. The investigator felt that participating in the study placed patients at unacceptable risk.
  • Patients with malignant tumors.
  • Patients with moderate to severe heart failure (New York Heart Society Grades 3-4).
  • History of severe allergy or anaphylactoid reaction to monoclonal antibodies.
  • Prior treatment with anti-TUMOR necrosis factor TNF or other biological agents with potential therapeutic effect for uveitis (excluding intravitreal anti-VEGF drugs).
  • During the 30 days prior to baseline, the combined dose of other immunosuppressant therapy increased or did not meet any of the following conditions: methotrexate MTX≤25mg/ week; Cyclosporine ≤4 mg/kg/ day; Mycophenolate (or equivalent dose of mycophenolate) ≤2g/ day; Azathioprine ≤175 mg/ day; Tacrolimus oral ≤8 mg/ day.
  • Received clinical trial drug intervention within 3 months prior to screening.
  • Received any live vaccine within 3 months prior to receiving the first dose of the study drug, or planned to receive live vaccine during the study period.
  • There are contraindications to dilatation drugs.
  • Patients judged unsuitable for inclusion by other investigators

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Peking Union Medical College Hospital

    Beijing

  • The Second Xiangya Hospital of Central South University

    Changsha

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

  • The second hospital of Jilin University

    Jilin City

  • Tianjin Medical University Eye Hospital

    Tianjin

  • Renmin Hospital of Wuhan University

    Wuhan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: A Multicenter, Prospective, Post-marketing Evaluation of QLETLI (Adalimumab Injection) Treatment Clinical Study on Efficacy and Safety of Non-infectious Uveitis (UV)

This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled.

Screening period (-2~0 weeks) ,Treatment period (1-22 weeks), Follow-up period, At the same time, plasma concentration will be determined

Read the detailed description

This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled.

Screening period (-2~0 weeks) : the inclusion and exclusion criteria were evaluated, and those meeting the criteria could enter the treatment period.

Treatment period (1-22 weeks) : Eligible subjects with non-infectious uveitis were given an initial subcutaneous injection of 80 mg at week 1, followed by a subcutaneous injection of 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (a total of 12 doses).

Follow-up period: Follow-up for safety and/or efficacy is recommended at 6, 12, 24, and 32 weeks after initiation of the study drug. A final visit will be made at 32 weeks. During the study, if the condition of the subjects or their symptoms and signs become worse, the investigator can adjust the use of drugs for uveitis other than study drugs according to the actual situation of the subjects.

At the same time, plasma concentration will be determined before D1, D78 (week 12), and D162 (week 24); Immunogenicity analysis was performed before D1 administration, before D78 (week 12), before D162 (week 24) and before D218 (week 32)

Conditions
Uveitis
Being tested
QLETLI
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QLETLIDrug

    80 mg was given subcutaneously at week 1, followed by 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (12 doses).

Study groups in NCT05180526
Study groupRoleWhat they receive
ExperimentalExperimental80 mg was given subcutaneously at week 1, followed by 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (12 doses).
Receives: Drug: QLETLI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of treatment failure

    Duration of treatment failure at 6 weeks of treatment or between 6 and 24 weeks of treatment (treatment failure is defined as meeting at least one of the following conditions in at least one eye:

    Measured: 6\12\24week

Secondary outcomes (7)

  1. treatment failure rate

    Treatment failure rate at each visit point from first administration to 24 weeks.Treatment failure was defined as meeting at least one of the following conditions in at least one eye: newly active inflammatory choroiditis or retinal vasculopathy [from baseline]; The anterior chamber cell grading or vitreous opacity grading did not reach ≦0.5+ during the 6 weeks visit, or the optimal condition did not improve in all visits after 6 weeks. Best corrected visual acuity decreased by ≧15 letters compared to best condition

    Measured: 6/12/24week

  2. Changes in ocular inflammation

    changes in anterior chamber cell grade

    Measured: 6/12/24week

  3. Changes in ocular inflammation

    changes in vitreous turbidity

    Measured: 6/12/24week

  4. Changes in ocular inflammation

    changes in macular edema

    Measured: 6/12/24week

  5. Changes in ocular inflammation

    changes in central retinal thickness

    Measured: 6/12/24week

  6. Changes in visual acuity

    Changes in visual acuity

    Measured: 6/12/24week

  7. Changes in visual function scale VFQ-25

    Changes in visual function scale VFQ-25

    Measured: 6/12/24week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start27 Dec 2021
  3. Primary completion5 Aug 2025
  4. Study completion5 Aug 2025

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180526
Sponsor's protocol ID
BAT-1406-006-CR
Status last verified
Oct 2026
First submitted
7 Dec 2021
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing QLETLI in people with Uveitis, run by Bio-Thera Solutions 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 31 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 13 Oct 2026. 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?

Duration of treatment failure (time frame: 6\12\24week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180526.

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 13 Oct 2026.

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