Clinical Trials in Italy / NCT04088409
Active, not recruiting
Phase 3
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
NCT04088409 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Uveitis
Investigational drug(s) / intervention(s)
Baricitinib: Administered orally
Adalimumab: Administered SC
Study summary
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.
Eligibility
Inclusion Criteria:
* Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
* Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX).
* Participants must have an inadequate response or intolerance to MTX.
* Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening.
* Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product.
Exclusion Criteria:
* Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
* Participants must not have any contraindications to adalimumab.
* Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib.
* Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant.
* Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
* Participants must not have a current or recent (\<4 weeks prior to baseline) infection.
* Participants must not have a positive test for hepatitis B virus (HBV) at screening.
* Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.
Primary outcome measure(s)
- Part A: Percentage of Responders for Baricitinib at Week 24 — Week 24
Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | France | |
| Hôpital Universitaire Necker Enfants Malades | Paris | France | |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | |
| Asklepios Klinik Sankt Augustin | Sankt Augustin | North Rhine-Westphalia | |
| HELIOS Klinikum Berlin-Buch | Berlin | Germany | |
| Charité Campus Virchow-Klinikum | Berlin | Germany | |
| Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari | Hamburg | Germany | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Lombardy | |
| Azienda Ospedaliero Universitaria Meyer | Florence | Italy | |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona | |
| Hospital Infantil Universitario Niño Jesús | Madrid | Madrid, Comunidad de | |
| Hospital Universitario La Paz | Madrid | Madrid, Comunidad de | |
| Hospital Universitario La Fe de Valencia | Valencia | Spain | |
| Bristol Royal Hospital for Children | Bristol | Bristol, City of | |
| Cambridge Clinical Research Facility | Cambridge | Cambridgeshire | |
| Alder Hey Children's Hospital | Liverpool | England | |
| Royal Victoria Infirmary | Newcastle upon Tyne | England | |
| University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire | |
| Great Ormond Street Hospital For Children NHS Foundation Trust | London | United Kingdom | |
| Sheffield Children's Hospital | Sheffield | United Kingdom |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04088409 on ClinicalTrials.gov ↗ ← All trials in Italy