NCT01647152

Ustekinumab for Active Sight-Threatening Uveitis

Withdrawn Phase 1, PHASE2 Last updated 5 December 2019

What this trial tests

Phase 1, PHASE2 trial testing Ustekinumab in Uveitis. Withdrawn.

Timeline

3 July 2012

Primary endpoint
30 June 2015

30 June 2015

Quick facts

Lead sponsor	National Eye Institute (NEI)
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Start date	3 July 2012
Primary completion	30 June 2015
Estimated completion	30 June 2015

Drugs / interventions tested

• Ustekinumab (ustekinumab) — full drug profile →

Conditions studied

• Uveitis — all drugs for Uveitis →

Sponsor

National Eye Institute (NEI)

Who can join

18 and older, any sex, with Uveitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Uveitis is an eye inflammation that can cause vision loss. It is treated with eye drops, drugs and sometimes surgery. In some people, treatment may not prevent vision loss. A type of white blood cells called T-cells often have a role in causing uveitis. In some cases of uveitis, T-cells attack the eye and cause inflammation. A drug called ustekinumab reduces inflammation from these T-cells. Researchers want to see if ustekinumab can be used to treat uveitis.

Objectives:

\- To see if ustekinumab can be used to treat uveitis.

Eligibility:

\- Individuals at least 18 years of age who have active uveitis that needs treatment.

Design:

* Participants will be screened with a physical exam, eye exam, and medical history. Blood and urine samples will be taken.
* Participants will have at least eight clinic visits during the 64-week study period. After the first visit, visits will occur at 2, 4, and 8 weeks, and then every 12 weeks.
* Participants will have a ustekinumab injection at the first study visit. They will have additional doses at the second and third visits, and then every 12 weeks until 1 year after the first dose (Week 52).
* Treatment will be monitored with frequent blood tests and eye exams. Other standard treatments for uveitis may be given as needed.
* There will be a final study visit 3 months after the last injection.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biotherapies in Uveitis.
   Leclercq M, Desbois AC, Domont F, Maalouf G, et al · · 2020 · cited 28× · PMID 33171664 · DOI 10.3390/jcm9113599
2. Understanding autoimmunity in the eye: from animal models to novel therapies.
   Caspi RR. · · 2014 · cited 23× · PMID 24641958
3. A Review of the Landscape of Targeted Immunomodulatory Therapies for Non-Infectious Uveitis.
   Sharma SM, Fu DJ, Xue K. · · 2018 · cited 9× · PMID 29189960 · DOI 10.1007/s40123-017-0115-5