search
Back to results

A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapirolizumab pegol
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, Dapirolizumab pegol, SLE, DZP

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
  • The participant completed one of the placebo controlled (PBO-controlled) parent studies within 4 weeks prior to entry to this study

Exclusion Criteria:

- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study

Sites / Locations

  • Sl0046 50328
  • Sl0046 50383
  • Sl0046 50275
  • Sl0046 50316
  • Sl0046 50339
  • Sl0046 50239
  • Sl0046 50362
  • Sl0046 50059
  • Sl0046 50329
  • Sl0046 50240
  • Sl0046 50474
  • Sl0046 50285
  • Sl0046 50015
  • Sl0046 50219
  • Sl0046 50273
  • Sl0046 50366
  • Sl0046 50334
  • Sl0046 50238
  • Sl0046 50001
  • Sl0046 50418
  • Sl0046 50050
  • Sl0046 60002
  • Sl0046 60003
  • Sl0046 60022
  • Sl0046 60011
  • Sl0046 60014
  • Sl0046 40123
  • Sl0046 40189
  • Sl0046 40380
  • Sl0046 50337
  • Sl0046 50259
  • Sl0046 50044
  • Sl0046 60015
  • Sl0046 60018
  • Sl0046 60013
  • Sl0046 60019
  • Sl0046 60006
  • Sl0046 60027
  • Sl0046 60016
  • Sl0046 60007
  • Sl0046 60031
  • Sl0046 40066
  • Sl0046 40386
  • Sl0046 40078
  • Sl0046 40402
  • Sl0046 40377
  • Sl0046 40507
  • Sl0046 40412
  • Sl0046 40411
  • Sl0046 40031
  • Sl0046 40499
  • Sl0046 40448
  • Sl0046 20108
  • Sl0046 50317
  • Sl0046 50250
  • Sl0046 50249
  • Sl0046 50271
  • Sl0046 50252
  • Sl0046 50251
  • Sl0046 60009
  • Sl0046 60023
  • Sl0046 40482
  • Sl0046 40119
  • Sl0046 40398
  • Sl0046 40502
  • Sl0046 40151
  • Sl0046 40044
  • Sl0046 40090
  • Sl0046 40097
  • Sl0046 40098
  • Sl0046 40397
  • Sl0046 40481
  • Sl0046 40382
  • Sl0046 40393
  • Sl0046 40341
  • Sl0046 40101
  • Sl0046 40099
  • Sl0046 20082
  • Sl0046 20113
  • Sl0046 20142
  • Sl0046 20095

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dapirolizumab pegol

Arm Description

Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs) during the study
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Incidence of serious treatment-emergent adverse events during the study
A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Results in persistent disability/incapacity Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

Secondary Outcome Measures

Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Achievement of LLDAS at ≥50% of all visits
Low lupus disease activity state (LLDAS) is defined as: No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit PGA ≤33 mm Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol
Achievement of BICLA response at Week 24
A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled: British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Achievement of BICLA response at Week 52
A study participant is considered to be a BICLA responder if all of the following is fulfilled: BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Achievement of BICLA response at Week 104
A study participant is considered to be a BICLA responder if all of the following is fulfilled: BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.

Full Information

First Posted
July 14, 2021
Last Updated
October 19, 2023
Sponsor
UCB Biopharma SRL
search

1. Study Identification

Unique Protocol Identification Number
NCT04976322
Brief Title
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
Official Title
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
April 10, 2029 (Anticipated)
Study Completion Date
April 10, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic lupus erythematosus, Dapirolizumab pegol, SLE, DZP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapirolizumab pegol
Arm Type
Experimental
Arm Description
Subjects will receive dapriolizumab pegol throughout the Treatment Period.
Intervention Type
Drug
Intervention Name(s)
Dapirolizumab pegol
Other Intervention Name(s)
DZP, CDP7657
Intervention Description
Subjects will receive dapirolizumab pegol at prespecified time-points.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) during the study
Description
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Title
Incidence of serious treatment-emergent adverse events during the study
Description
A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Results in persistent disability/incapacity Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Title
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Description
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Secondary Outcome Measure Information:
Title
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
Description
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Time Frame
Week 24
Title
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
Description
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Time Frame
Week 52
Title
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
Description
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Time Frame
Week 104
Title
Achievement of LLDAS at ≥50% of all visits
Description
Low lupus disease activity state (LLDAS) is defined as: No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit PGA ≤33 mm Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol
Time Frame
From Baseline (Day 1) until End of Treatment (Week 104)
Title
Achievement of BICLA response at Week 24
Description
A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled: British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Time Frame
Week 24
Title
Achievement of BICLA response at Week 52
Description
A study participant is considered to be a BICLA responder if all of the following is fulfilled: BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Time Frame
Week 52
Title
Achievement of BICLA response at Week 104
Description
A study participant is considered to be a BICLA responder if all of the following is fulfilled: BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Time Frame
Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment The participant completed one of the placebo controlled (PBO-controlled) parent studies within 4 weeks prior to entry to this study Exclusion Criteria: - Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Sl0046 50328
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Sl0046 50383
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Sl0046 50275
City
La Palma
State/Province
California
ZIP/Postal Code
90623-1730
Country
United States
Facility Name
Sl0046 50316
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Sl0046 50339
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Sl0046 50239
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Sl0046 50362
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Sl0046 50059
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Sl0046 50329
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Sl0046 50240
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Sl0046 50474
City
Hopkinsville
State/Province
Kentucky
ZIP/Postal Code
42240-1746
Country
United States
Facility Name
Sl0046 50285
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Sl0046 50015
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Sl0046 50219
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sl0046 50273
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Sl0046 50366
City
Canton
State/Province
New York
ZIP/Postal Code
13617
Country
United States
Facility Name
Sl0046 50334
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Sl0046 50238
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Sl0046 50001
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Sl0046 50418
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Sl0046 50050
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Sl0046 60002
City
Buenos Aires
Country
Argentina
Facility Name
Sl0046 60003
City
Quilmes
Country
Argentina
Facility Name
Sl0046 60022
City
Quilmes
Country
Argentina
Facility Name
Sl0046 60011
City
San Juan
Country
Argentina
Facility Name
Sl0046 60014
City
Tucuman
Country
Argentina
Facility Name
Sl0046 40123
City
Bruxelles
Country
Belgium
Facility Name
Sl0046 40189
City
Plovdiv
Country
Bulgaria
Facility Name
Sl0046 40380
City
Sofia
Country
Bulgaria
Facility Name
Sl0046 50337
City
Edmonton Ab
Country
Canada
Facility Name
Sl0046 50259
City
Rimouski
Country
Canada
Facility Name
Sl0046 50044
City
Trois-rivieres
Country
Canada
Facility Name
Sl0046 60015
City
Santiago de Chile
Country
Chile
Facility Name
Sl0046 60018
City
Santiago
Country
Chile
Facility Name
Sl0046 60013
City
Barranquilla
Country
Colombia
Facility Name
Sl0046 60019
City
Barranquilla
Country
Colombia
Facility Name
Sl0046 60006
City
Bogota
Country
Colombia
Facility Name
Sl0046 60027
City
Bogota
Country
Colombia
Facility Name
Sl0046 60016
City
Bucaramanga
Country
Colombia
Facility Name
Sl0046 60007
City
Chia
Country
Colombia
Facility Name
Sl0046 60031
City
Monteria
Country
Colombia
Facility Name
Sl0046 40066
City
Praha 2
Country
Czechia
Facility Name
Sl0046 40386
City
Cologne
Country
Germany
Facility Name
Sl0046 40078
City
Leipzig
Country
Germany
Facility Name
Sl0046 40402
City
Tübingen
Country
Germany
Facility Name
Sl0046 40377
City
Crete
Country
Greece
Facility Name
Sl0046 40507
City
Larisa
Country
Greece
Facility Name
Sl0046 40412
City
Budapest
Country
Hungary
Facility Name
Sl0046 40411
City
Debrecen
Country
Hungary
Facility Name
Sl0046 40031
City
Szeged
Country
Hungary
Facility Name
Sl0046 40499
City
Szekesfehervar
Country
Hungary
Facility Name
Sl0046 40448
City
Milano
Country
Italy
Facility Name
Sl0046 20108
City
Incheon
Country
Korea, Republic of
Facility Name
Sl0046 50317
City
Chihuahua
Country
Mexico
Facility Name
Sl0046 50250
City
Cuernavaca
Country
Mexico
Facility Name
Sl0046 50249
City
Guadalajara
Country
Mexico
Facility Name
Sl0046 50271
City
Leon
Country
Mexico
Facility Name
Sl0046 50252
City
Merida
Country
Mexico
Facility Name
Sl0046 50251
City
Monterrey
Country
Mexico
Facility Name
Sl0046 60009
City
Lima
Country
Peru
Facility Name
Sl0046 60023
City
Lima
Country
Peru
Facility Name
Sl0046 40482
City
Bialystok
Country
Poland
Facility Name
Sl0046 40119
City
Bydgoszcz
Country
Poland
Facility Name
Sl0046 40398
City
Katowice
Country
Poland
Facility Name
Sl0046 40502
City
Krakow
Country
Poland
Facility Name
Sl0046 40151
City
Lublin
Country
Poland
Facility Name
Sl0046 40044
City
Poznan
Country
Poland
Facility Name
Sl0046 40090
City
Poznan
Country
Poland
Facility Name
Sl0046 40097
City
Warszawa
Country
Poland
Facility Name
Sl0046 40098
City
Warszawa
Country
Poland
Facility Name
Sl0046 40397
City
Wroclaw
Country
Poland
Facility Name
Sl0046 40481
City
Wroclaw
Country
Poland
Facility Name
Sl0046 40382
City
Galati
Country
Romania
Facility Name
Sl0046 40393
City
Belgrade
Country
Serbia
Facility Name
Sl0046 40341
City
Málaga
Country
Spain
Facility Name
Sl0046 40101
City
Sabadell
Country
Spain
Facility Name
Sl0046 40099
City
Vigo
Country
Spain
Facility Name
Sl0046 20082
City
Kuei-san Hsiang
Country
Taiwan
Facility Name
Sl0046 20113
City
Taichung City
Country
Taiwan
Facility Name
Sl0046 20142
City
Taichung City
Country
Taiwan
Facility Name
Sl0046 20095
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
https://www.Vivli.org

Learn more about this trial

A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

We'll reach out to this number within 24 hrs