A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

• Register: EUCTR
• Last refreshed on: 21 October 2024
• Main ID: EUCTR2019-003406-27-IT
• Date of registration: 21/01/2021
• Prospective Registration: No
• Primary sponsor: UCB Biopharma SRL
• Public title: A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - -
• Date of first enrolment: 07/10/2020
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003406-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czech Republic, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Lithuania, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Study participant must be > or = 16 years of age - Study participants who have moderate to severe disease activity due toeither persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC)medication defined as: a. Diagnosed with SLE at least 24 weeks before study entry by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)classification criteria for SLE c. With serological evidence for SLE as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (in central laboratory at Screening) ii) Either complement C3 < lower limit of normal (LLN) OR complement C4 3. Historic evidence for anti-dsDNA antibodies d. Moderately to severely active defined as -British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in > or = 2 organ systems and/or a BILAG 2004 Grade A in > or = 1 organ systems at Screening and Baseline Visit AND -Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) > or = 6 at Screening Visit AND -SLEDAI-2K without labs > or = 4 at Baseline Visit
e. Receiving the following SOC mediation at stable dose: ¿ Anti-malarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR ¿ Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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
- Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies - Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma - Study participants with a history of thromboembolic events within 52 weeks of Screening or with a history of catastrophic antiphospholipid syndrome (APS) or saddle pulmonary embolism or with a vascular graft, valvular heart disease, atrial fibrillation, or any other heart rhythm disorder associated with an increased risk for thromboembolic events
- Study participant has evidence of human immunodeficiency virus (HIV)infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection - Study participant had an opportunistic infection within 12 weeks prior to the first study medication infusion. - Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion - Study participant has clinically significant active or latent infection - Study participant has a mixed connective tissue disease, scleroderma and/or overlap syndrome of these diseases with SLE - Study participant takes any protocol defined prohibited concomitant medication or has active lupus that, in the opinion of the Investigator or according to local or international guidances, requires prohibited concomitant medications - Study participant has previously been assigned to treatment with DZP in a study evaluating dapirolizumab pegol (DZP) - Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP - Study participant has chronic kidney failure, manifested by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2, or serum creatinine >2.5 mg/dL, or proteinuria >3 g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Immune system processes [G12]

Systemic lupus erythematosus (SLE)
MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Dapirolizumab pegol
Product Code: [CDP7657]
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Dapirolizumab pegol
Current Sponsor code: DZP
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: Evaluate the ability of DZP as an add-on treatment to SOC medication:
- to achieve fast, clinically relevant improvement of moderate to severe disease activity
- to achieve long term control of disease activity
- to achieve and maintain the treat-to-target goal: low disease activity with low/acceptable corticosteroid dose over time
- to achieve improvement of disease activity as measured by numerical disease state score commonly used in clinical practice
- to achieve components of the composite primary endpoints
- to achieve alternative responder endpoint
- to achieve endpoints supporting other key secondary endpoints

To evaluate the safety and tolerability of DZP as add-on treatment to SOC medication.

Main Objective: Evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

Primary end point(s): Achievement of BICLA response at Week 48.

Timepoint(s) of evaluation of this end point: Week 48

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1: Week 24
2: Week 12
3, 4, 5, 6, 8, 9: Week 48
7: From Baseline (Day 1) to Week 48
10, 11: During Treatment Period up to Week 48
12, 13, 14, 15: From Baseline (Day 1) until Safety Follow-Up (up to Week54)

Secondary end point(s): 1. Achievement of BICLA response at Week 24
2. Achievement of BICLA response at Week 12
3. Achievement of prevention of severe BILAG flares through Week 48
4. Achievement of LLDAS in =50% of post-Baseline visits through Week 48
5. Change from Baseline in SLEDAI-2K at Week 48
6. Achievement of BILAG improvement without worsening at Week 48
7. Change from Baseline in PGA at Week 48
8. Achievement of SRI4 response at Week 48
9. Achievement of prevention of moderate/severe BILAG flares through Week 48
10. Time to severe BILAG Flare through Week 48
11. Time to moderate/severe BILAG flare through Week 48
12. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
13. Percentage of participants with serious treatment-emergent adverse events during the study
14. Percentage of participants with treatment-emergent adverse events of special interest during the study
15. Percentage of participants with treatment-emergent adverse events of special monitoring during the study

Secondary ID(s)

SL0043

2019-003406-27-BE

Source(s) of Monetary Support

UCB Biopharma SRL

Ethics review

Status: Approved
Approval date: 06/10/2020
Contact: