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Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IFNα-Kinoid
Placebo
ISA 51 VG
Sponsored by
Neovacs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IFNα-Kinoid

Placebo

Arm Description

IFNα-Kinoid (IFN-K) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at W0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.

Placebo normal saline (0.9% Sodium Chloride) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at week (W)0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in IFN Gene Signature at W36
The biological endpoint aimed at evaluating the neutralization of the IFN gene signature following treatment with IFN-K compared to placebo, as measured by the % change from baseline of the expression of IFN-induced genes.
Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responder was defined as a subject who had the following criteria at week 36: All BILAG A scores at baseline improve to B/C/D and all BILAG B scores improve to C/D at W36, and No BILAG worsening in other body systems: no new BILAG A or ≥ 2 new BILAG B scores at W36, and No worsening in SLEDAI-2K total score at W36 compared with baseline, and No deterioration in Physician Global Assessment (PGA) (< 10% worsening) on Visual Analog Scale (VAS) 100 mm at W36 compared with baseline, and No addition or increased dose level of anti-malarial drugs or immunosuppressive drugs or CS* between W24 and W36 (*≤5 mg prednisolone or equivalent /day at W24 and no increase until W36).

Secondary Outcome Measures

Number of Participants Who Achieved a Systematic Lupus Erythematosus (SLE) Responder Index (SRI)-4 at Week 36
SLE Responder Index (SRI); SRI-4 responder was defined as a subject who had the following criteria at week 36: reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and no new BILAG A at week 36, and no more than 1 new BILAG B at week 36, and no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline
Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) at Week 36
Lupus low disease activity state (LLDAS) was conceptually defined as 'a state which, if sustained, is associated with a low likelihood of adverse outcome, considering disease activity and medication safety'. Subsequently defined using consensus methodology, LLDAS is attained if all the following items are met: SLEDAI-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity No new features of lupus disease activity compared with the previous assessment SELENA-SLEDAI physician global assessment (PGA, scale 0-3) ≤1 Current prednisolone (or equivalent) dose ≤7.5 mg daily Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs
BILAG Global Score Change From Baseline to Last Available Value (LVA) Between Week 24 and Week 36
British Isles Lupus Assessment Group (BILAG)-2004 index, it categorizes disease activity into 5 different levels from A to E, with Grade A representing very active disease and Grade E indicating no current or previous disease activity. Scoring was based on a total of 101 items, grouped into 9 organ/systems and the summation of the numerical values for the nine-system scores was given by the following formula: Numerical global score = A*12 + B*8 + C*1, where A, B and C represent the number of Grades A, B and C respectively at each assessment. Grades D and E are considered as 0 (Chee-Seng Yee et al, 2010). The minimum score is 0 with no predefined maximum. The higher scores mean a worse outcome. The BILAG global score change from baseline to Last Available Value (LVA) week 24 and week 36 were presented analyzed.
SELENA-SLEDAI - Change From Baseline to Week 36
Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI, is a slightly modified version of the SLEDAI. This is a weighted index in which signs and symptoms, laboratory tests, and Physician's Global Assessment (PGA) for each of nine organ systems are given a weighted score and summed up if present at the time of the visit or in the preceding 10 days. The maximum theoretical score for the SELENA SLEDAI is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease.
SLICC/ACR-DI Change From Baseline at Week 36
Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for systemic lupus erythematosus (SLICC/ACR-DI) captures permanent changes which have occurred in patients with SLE, regardless of causality. The questionnaire contains 41 items covering 12 different organ systems. The score of items ranges from 1 to 3 and the total score from 0 to 47. By definition score 0 corresponds to diagnostics and damage over time can only be stable or increase, theoretically to a maximum of 47 points.
CLASI Total Activity Change From Baseline at Week 36
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was specifically developed to assess the cutaneous manifestations of SLE. It measures both disease activity and permanent damage (e.g. dyspigmentation and scarring) over the entire body surface. CLASI total activity score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Number of Participants Who Achieved a Composite SRI-4 Including CS ≤7,5mg/Day at Week 36
SRI (4) plus CS ≤ 7.5 mg/day responder was defined as a participant who had the following criteria at week 36: reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and no new BILAG A at week 36, and no more than 1 new BILAG B at week 36, and no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus CS ≤7.5mg equivalent prednisolone per day at week 36
Number of Participants Who Achieved a Composite SRI-4 Including CS ≤5mg/Day at Week 36
SRI-4 plus CS ≤ 5mg/day responder was defined as a participant who had the following criteria at Week 36: reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and no new BILAG A at week 36, and no more than 1 new BILAG B at week 36, and no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus corticosteroids (CS) ≤5mg equivalent prednisolone per day at week 36
Number of Participants With Neutralizing Anti-IFN-alpha Antibodies at W36
Individual serum antibody neutralizing capacity against recombinant IFN-alpha2b was measured by reporter gene assay using Interferon Sensitive Response Element (ISRE) reporter.
Number of Participants With Treatment-related Adverse Events
Number of participants who reported any treatment-related adverse events until month 9

Full Information

First Posted
November 17, 2015
Last Updated
March 31, 2020
Sponsor
Neovacs
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1. Study Identification

Unique Protocol Identification Number
NCT02665364
Brief Title
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
Official Title
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Reorganization proceedings of the sponsor
Study Start Date
September 23, 2015 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neovacs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response. The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IFNα-Kinoid
Arm Type
Experimental
Arm Description
IFNα-Kinoid (IFN-K) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at W0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo normal saline (0.9% Sodium Chloride) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at week (W)0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.
Intervention Type
Biological
Intervention Name(s)
IFNα-Kinoid
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Other
Intervention Name(s)
ISA 51 VG
Primary Outcome Measure Information:
Title
Percent Change From Baseline in IFN Gene Signature at W36
Description
The biological endpoint aimed at evaluating the neutralization of the IFN gene signature following treatment with IFN-K compared to placebo, as measured by the % change from baseline of the expression of IFN-induced genes.
Time Frame
Baseline and Last Available Value (LVA) between week 24 and week 36
Title
Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36
Description
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responder was defined as a subject who had the following criteria at week 36: All BILAG A scores at baseline improve to B/C/D and all BILAG B scores improve to C/D at W36, and No BILAG worsening in other body systems: no new BILAG A or ≥ 2 new BILAG B scores at W36, and No worsening in SLEDAI-2K total score at W36 compared with baseline, and No deterioration in Physician Global Assessment (PGA) (< 10% worsening) on Visual Analog Scale (VAS) 100 mm at W36 compared with baseline, and No addition or increased dose level of anti-malarial drugs or immunosuppressive drugs or CS* between W24 and W36 (*≤5 mg prednisolone or equivalent /day at W24 and no increase until W36).
Time Frame
At Week 36
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved a Systematic Lupus Erythematosus (SLE) Responder Index (SRI)-4 at Week 36
Description
SLE Responder Index (SRI); SRI-4 responder was defined as a subject who had the following criteria at week 36: reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and no new BILAG A at week 36, and no more than 1 new BILAG B at week 36, and no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline
Time Frame
W36 (9 months)
Title
Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) at Week 36
Description
Lupus low disease activity state (LLDAS) was conceptually defined as 'a state which, if sustained, is associated with a low likelihood of adverse outcome, considering disease activity and medication safety'. Subsequently defined using consensus methodology, LLDAS is attained if all the following items are met: SLEDAI-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity No new features of lupus disease activity compared with the previous assessment SELENA-SLEDAI physician global assessment (PGA, scale 0-3) ≤1 Current prednisolone (or equivalent) dose ≤7.5 mg daily Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs
Time Frame
At Week 36
Title
BILAG Global Score Change From Baseline to Last Available Value (LVA) Between Week 24 and Week 36
Description
British Isles Lupus Assessment Group (BILAG)-2004 index, it categorizes disease activity into 5 different levels from A to E, with Grade A representing very active disease and Grade E indicating no current or previous disease activity. Scoring was based on a total of 101 items, grouped into 9 organ/systems and the summation of the numerical values for the nine-system scores was given by the following formula: Numerical global score = A*12 + B*8 + C*1, where A, B and C represent the number of Grades A, B and C respectively at each assessment. Grades D and E are considered as 0 (Chee-Seng Yee et al, 2010). The minimum score is 0 with no predefined maximum. The higher scores mean a worse outcome. The BILAG global score change from baseline to Last Available Value (LVA) week 24 and week 36 were presented analyzed.
Time Frame
Last Available Value (LVA) between week 24 and week 36
Title
SELENA-SLEDAI - Change From Baseline to Week 36
Description
Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI, is a slightly modified version of the SLEDAI. This is a weighted index in which signs and symptoms, laboratory tests, and Physician's Global Assessment (PGA) for each of nine organ systems are given a weighted score and summed up if present at the time of the visit or in the preceding 10 days. The maximum theoretical score for the SELENA SLEDAI is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease.
Time Frame
Baseline and Week 36
Title
SLICC/ACR-DI Change From Baseline at Week 36
Description
Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for systemic lupus erythematosus (SLICC/ACR-DI) captures permanent changes which have occurred in patients with SLE, regardless of causality. The questionnaire contains 41 items covering 12 different organ systems. The score of items ranges from 1 to 3 and the total score from 0 to 47. By definition score 0 corresponds to diagnostics and damage over time can only be stable or increase, theoretically to a maximum of 47 points.
Time Frame
Baseline and Week 36
Title
CLASI Total Activity Change From Baseline at Week 36
Description
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was specifically developed to assess the cutaneous manifestations of SLE. It measures both disease activity and permanent damage (e.g. dyspigmentation and scarring) over the entire body surface. CLASI total activity score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Time Frame
Baseline and Week 36
Title
Number of Participants Who Achieved a Composite SRI-4 Including CS ≤7,5mg/Day at Week 36
Description
SRI (4) plus CS ≤ 7.5 mg/day responder was defined as a participant who had the following criteria at week 36: reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and no new BILAG A at week 36, and no more than 1 new BILAG B at week 36, and no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus CS ≤7.5mg equivalent prednisolone per day at week 36
Time Frame
At Week 36
Title
Number of Participants Who Achieved a Composite SRI-4 Including CS ≤5mg/Day at Week 36
Description
SRI-4 plus CS ≤ 5mg/day responder was defined as a participant who had the following criteria at Week 36: reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and no new BILAG A at week 36, and no more than 1 new BILAG B at week 36, and no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus corticosteroids (CS) ≤5mg equivalent prednisolone per day at week 36
Time Frame
At Week 36
Title
Number of Participants With Neutralizing Anti-IFN-alpha Antibodies at W36
Description
Individual serum antibody neutralizing capacity against recombinant IFN-alpha2b was measured by reporter gene assay using Interferon Sensitive Response Element (ISRE) reporter.
Time Frame
At week 36
Title
Number of Participants With Treatment-related Adverse Events
Description
Number of participants who reported any treatment-related adverse events until month 9
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
CS Mean Daily Dose at W36
Description
mean daily dose of corticosteroid (CS) (prednisone equivalent)
Time Frame
At W36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Houssiau, MD, PhD
Organizational Affiliation
Head of Rhumatology, UCL, Brussels, Belgium
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7501126
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7510047
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Research Site
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Research Site
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Research Site
City
Zipaquira
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Research Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Research Site
City
Pessac
State/Province
Bordeaux
ZIP/Postal Code
33600
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Research site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Research site
City
Bad-Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
130625
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
Munich
ZIP/Postal Code
80639
Country
Germany
Facility Name
Research Site
City
Rome
State/Province
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Name
Research Site
City
Cuernavaca
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44500
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Research Site
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Research Site
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Research Site
City
Chisinau
ZIP/Postal Code
2026
Country
Moldova, Republic of
Facility Name
Research Site
City
Lima
ZIP/Postal Code
13
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
29
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Research Site
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Research Site
City
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Research Site
City
Quezon
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Research Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Research Site
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
71 - 252
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644111
Country
Russian Federation
Facility Name
Research Site
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196066
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Research Site
City
Yekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40402
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Sfax
ZIP/Postal Code
3029
Country
Tunisia
Facility Name
Research Site
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
Research Site
City
Sousse
Country
Tunisia
Facility Name
Research Site
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Research Site
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
PubMed Identifier
31871140
Citation
Houssiau FA, Thanou A, Mazur M, Ramiterre E, Gomez Mora DA, Misterska-Skora M, Perich-Campos RA, Smakotina SA, Cerpa Cruz S, Louzir B, Croughs T, Tee ML. IFN-alpha kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study. Ann Rheum Dis. 2020 Mar;79(3):347-355. doi: 10.1136/annrheumdis-2019-216379. Epub 2019 Dec 23.
Results Reference
derived

Learn more about this trial

Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

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