Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02665364
• Date of registration: 17/11/2015
• Prospective Registration: No
• Primary sponsor: Neovacs
• Public title: Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
• Scientific title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: September 23, 2015
• Target sample size: 185
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02665364
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Belgium, Chile, Colombia, Croatia, France, Georgia, Germany, Italy, Korea, Republic of, Mexico, Moldova, Republic of, Peru, Philippines, Poland, Russian Federation, Switzerland, Taiwan, Thailand, Tunisia, United States

Contacts

• Name: Frédéric Houssiau, MD, PhD
• Affiliation: Head of Rhumatology, UCL, Brussels, Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has had a diagnosis of SLE according to current American College of Rheumatology (ACR)
criteria (4 of 11 ACR criteria)

- Has SLEDAI-2K = 6

- Has at least 1 BILAG A and/or at least 2 BILAG B

- Has a positive IFN gene signature by reverse transcription quantitative polymerase
chain reaction (RT-qPCR)

- Has anti-nuclear antibodies (ANA) = 1:160 and/or anti-dsDNA antibodies = 7.0 IU/mL

- Currently receiving at least one treatment for SLE

Exclusion Criteria:

- Has active, severe lupus nephritis as defined either by the immediate need for
cyclophosphamide treatment or by renal BILAG A

- Has active, severe, neuropsychiatric SLE, defined as neuropsychiatric BILAG A

- Has been treated with corticosteroids (CS) at a dose of >20 mg of prednisone
equivalent/day for > 7 consecutive days

- Is currently receiving or has received pulse dose CS (= 250 mg prednisone
equivalent/day)

- Has received potent immunosuppressive drugs

- Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, tumor
necrosis factor (TNF) antagonists or another registered or investigational biological
therapy

- Has received anti-B-cell therapy (e.g., rituximab, epratuzumab)

- Has frequent recurrences of oral or genital herpes simplex lesions

- Is at high risk of significant infection and/or has any current signs or symptoms of
infection at entry or has received intravenous antibiotics

- Has received any live vaccine

- Has used any investigational or non-registered product or any investigational or
non-registered vaccine

- Is high-risk human papilloma virus (HPV) positive by rRT-qPCR on a cervical swab

- Has cytological abnormalities = high grade squamous intraepithelial lesions (HSIL) on
a cervical swab



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: IFNa-Kinoid

Other: ISA 51 VG

Other: Placebo

Primary Outcome(s)

Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36 [Time Frame: At Week 36]

Percent Change From Baseline in IFN Gene Signature at W36 [Time Frame: Baseline and Last Available Value (LVA) between week 24 and week 36]

Secondary Outcome(s)

Number of Participants Who Achieved a Composite SRI-4 Including CS =7,5mg/Day at Week 36 [Time Frame: At Week 36]

Number of Participants Who Achieved a Systematic Lupus Erythematosus (SLE) Responder Index (SRI)-4 at Week 36 [Time Frame: W36 (9 months)]

SLICC/ACR-DI Change From Baseline at Week 36 [Time Frame: Baseline and Week 36]

Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) at Week 36 [Time Frame: At Week 36]

Number of Participants With Neutralizing Anti-IFN-alpha Antibodies at W36 [Time Frame: At week 36]

CLASI Total Activity Change From Baseline at Week 36 [Time Frame: Baseline and Week 36]

Number of Participants Who Achieved a Composite SRI-4 Including CS =5mg/Day at Week 36 [Time Frame: At Week 36]

BILAG Global Score Change From Baseline to Last Available Value (LVA) Between Week 24 and Week 36 [Time Frame: Last Available Value (LVA) between week 24 and week 36]

Number of Participants With Treatment-related Adverse Events [Time Frame: 9 months]

SELENA-SLEDAI - Change From Baseline to Week 36 [Time Frame: Baseline and Week 36]

Secondary ID(s)

IFN-K-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02665364