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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04976322
• Other study ID #: SL0046
• Secondary ID: 2019-003409-83
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: July 27, 2021
• Est. completion date: April 10, 2029

Study information

• Verified date: May 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 760
• Est. completion date: April 10, 2029
• Est. primary completion date: April 10, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Dapirolizumab pegol
Subjects will receive dapirolizumab pegol at prespecified time-points.

Locations

Country	Name	City	State
Argentina	Sl0046 60002	Buenos Aires
Argentina	Sl0046 60029	Mendoza
Argentina	Sl0046 60003	Quilmes
Argentina	Sl0046 60022	Quilmes
Argentina	Sl0046 60011	San Juan
Argentina	Sl0046 60014	Tucuman
Belgium	Sl0046 40123	Bruxelles
Bulgaria	Sl0046 40189	Plovdiv
Bulgaria	Sl0046 40380	Sofia
Canada	Sl0046 50374	Calgary
Canada	Sl0046 50337	Edmonton Ab
Canada	Sl0046 50259	Rimouski
Canada	Sl0046 50045	Toronto
Chile	Sl0046 60018	Santiago
Chile	Sl0046 60015	Santiago de Chile
Colombia	Sl0046 60013	Barranquilla
Colombia	Sl0046 60019	Barranquilla
Colombia	Sl0046 60006	Bogota
Colombia	Sl0046 60027	Bogota
Colombia	Sl0046 60016	Bucaramanga
Colombia	Sl0046 60007	Chia
Colombia	Sl0046 60031	Monteria
Czechia	Sl0046 40066	Praha 2
Germany	Sl0046 40386	Cologne
Germany	Sl0046 40027	Herne
Germany	Sl0046 40078	Leipzig
Germany	Sl0046 40402	Tübingen
Greece	Sl0046 40378	Athens
Greece	Sl0046 40377	Crete
Greece	Sl0046 40501	Haidari - Athens
Greece	Sl0046 40507	Larisa
Hungary	Sl0046 40412	Budapest
Hungary	Sl0046 40411	Debrecen
Hungary	Sl0046 40031	Szeged
Hungary	Sl0046 40499	Szekesfehervar
Italy	Sl0046 40084	Catania
Italy	Sl0046 40448	Milano
Korea, Republic of	Sl0046 20108	Incheon
Korea, Republic of	Sl0046 20104	Seoul
Mexico	Sl0046 50317	Chihuahua
Mexico	Sl0046 50250	Cuernavaca
Mexico	Sl0046 50249	Guadalajara
Mexico	Sl0046 50271	Leon
Mexico	Sl0046 50252	Merida
Mexico	Sl0046 50251	Monterrey
Peru	Sl0046 60009	Lima
Peru	Sl0046 60023	Lima
Philippines	Sl0046 20181	Makati
Poland	Sl0046 40482	Bialystok
Poland	Sl0046 40119	Bydgoszcz
Poland	Sl0046 40398	Katowice
Poland	Sl0046 40502	Krakow
Poland	Sl0046 40151	Lublin
Poland	Sl0046 40044	Poznan
Poland	Sl0046 40090	Poznan
Poland	Sl0046 40097	Warszawa
Poland	Sl0046 40098	Warszawa
Poland	Sl0046 40397	Wroclaw
Poland	Sl0046 40481	Wroclaw
Romania	Sl0046 40382	Galati
Serbia	Sl0046 40393	Belgrade
Serbia	Sl0046 40461	Belgrade
Spain	Sl0046 40160	Barcelona
Spain	Sl0046 40341	Málaga
Spain	Sl0046 40101	Sabadell
Spain	Sl0046 40099	Vigo
Taiwan	Sl0046 20113	Taichung City
Taiwan	Sl0046 20142	Taichung City
Taiwan	Sl0046 20095	Taipei
Taiwan	Sl0046 20082	Taoyuan City
United States	Sl0046 50368	Atlanta	Georgia
United States	Sl0046 50050	Beckley	West Virginia
United States	Sl0046 50383	Beverly Hills	California
United States	Sl0046 50239	Brandon	Florida
United States	Sl0046 50366	Canton	New York
United States	Sl0046 50238	Charlotte	North Carolina
United States	Sl0046 50418	Colleyville	Texas
United States	Sl0046 50339	Denver	Colorado
United States	Sl0046 50219	Detroit	Michigan
United States	Sl0046 50362	Gainesville	Florida
United States	Sl0046 50015	Hagerstown	Maryland
United States	Sl0046 50147	Hershey	Pennsylvania
United States	Sl0046 50474	Hopkinsville	Kentucky
United States	Sl0046 50240	Idaho Falls	Idaho
United States	Sl0046 50001	Jackson	Tennessee
United States	Sl0046 50275	La Palma	California
United States	Sl0046 50285	Lake Charles	Louisiana
United States	Sl0046 50273	Las Vegas	Nevada
United States	Sl0046 50334	New York	New York
United States	Sl0046 50059	Ormond Beach	Florida
United States	Sl0046 50324	Plantation	Florida
United States	Sl0046 50316	San Leandro	California
United States	Sl0046 50329	Tampa	Florida
United States	Sl0046 50328	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Serbia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Primary	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	From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Primary	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.	From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Secondary	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).	Week 24
Secondary	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).	Week 52
Secondary	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).	Week 104
Secondary	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	From Baseline (Day 1) until End of Treatment (Week 104)
Secondary	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.	Week 24
Secondary	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.	Week 52
Secondary	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.	Week 104