ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02955615
• Date of registration: 17/10/2016
• Prospective Registration: Yes
• Primary sponsor: Iltoo Pharma
• Public title: ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) LUPIL-2
• Scientific title: A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: January 18, 2017
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02955615
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Austria, Bulgaria, France, Germany, Italy, Mauritius, Mexico, Portugal, Romania, Spain

Contacts

• Name: David Klatzmann, MD, PhD
• Affiliation: Assistance Publique Hôpitaux de Paris (AP-HP)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of SLE

- Active SLE

- On stable background therapy for 1 month

- Using highly effective contraception

Exclusion Criteria:

- Serious organ failure (renal functional impairment, severe central nervous system
manifestations, severe heart failure, liver failure)

- Any clinical evidence of active chronic infection HIV, hepatitis B, hepatitis C

- Clinical significant pleuritis or pericarditis

- Type1 Diabetes and/or CROHN's disease

- Use of Benlysta (belimumab) in the past 4 weeks

- Use of Rituximab in the past 6 months

- Vaccination with live attenuated virus in the last month



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: ILT-101

Primary Outcome(s)

SRI-4 (SLE responder index) [Time Frame: at week 12]

Secondary Outcome(s)

Incidence of adverse events [Time Frame: From baseline up to week 24 or 36]

%Tregs [Time Frame: From baseline to week 12 or 24]

Anti ds-DNA by immunology-based assay [Time Frame: From baseline to week 12 or 24]

Number of participants able to reduce oral steroid dose of 25 and 50% [Time Frame: From baseline to week 12 or 24]

Secondary ID(s)

2016-000488-17

2016-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors