Trial record 1 of 1 for: Dapirolizumab Pegol

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A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

This study is currently recruiting participants.

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Contacts and Locations

Verified May 2017 by UCB Pharma ( UCB Biopharma S.P.R.L. )

Sponsor:

Information provided by (Responsible Party):

UCB Pharma ( UCB Biopharma S.P.R.L. )

ClinicalTrials.gov Identifier:

NCT02804763

First received: June 14, 2016

Last updated: May 3, 2017

Last verified: May 2017

History of Changes

Purpose

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus receiving stable standard-of-care medications.

Condition	Intervention	Phase
Systemic Lupus Erythematosus (SLE)	Drug: Placebo Drug: Dapirolizumab pegol (DZP)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

Resource links provided by NLM:

Genetics Home Reference related topics: systemic lupus erythematosus

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):

Primary Outcome Measures:

Percentage of subjects with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures:

The percentage of subjects with BICLA response in the individual dose groups at Week 24 [ Time Frame: Week 24 ]


Estimated Enrollment:	160
Study Start Date:	June 2016
Estimated Study Completion Date:	July 2018
Estimated Primary Completion Date:	March 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Standard-of-care + Placebo Placebo in a specified sequence for a total of 24 weeks	Drug: Placebo Solution for infusion, 0,9% saline
Experimental: Standard-of-care + DZP dose 1 Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP) Solution for infusion
Experimental: Standard-of-care + DZP dose 2 Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP) Solution for infusion
Experimental: Standard-of-care + DZP dose 3 Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks	Drug: Dapirolizumab pegol (DZP) Solution for infusion

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by SLICC classification criteria
Moderate to severe SLE disease activity
Evidence for at least 1 of the following SLE markers:
- Anti-dsDNA antibodies confirmed by central laboratory or
- Low complement confirmed by central laboratory or
- Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for anti-ENA confirmed by central laboratory
The subject is receiving stable SLE standard-of-care medication

Exclusion Criteria:

Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE
Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
New or worsening Class III or IV lupus nephritis
Chronic kidney failure stage 3b
Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)
Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection
Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug
History of thromboembolic events within 12 months of screening
Subject has used protocol defined prohibited medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02804763

Contacts


Contact: UCB Cares	+1 844 599 ext 2273	UCBCares@ucb.com

Show 71 Study Locations

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators


Study Director:	UCB Cares	+1 844 599 2273 (UCB)

More Information


Responsible Party:	UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier:	NCT02804763 History of Changes
Other Study ID Numbers:	SL0023 2015-004457-40 ( EudraCT Number )
Study First Received:	June 14, 2016
Last Updated:	May 3, 2017

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):


Systemic Lupus Erythematosus (SLE) Dapirolizumab Pegol (DZP)

Additional relevant MeSH terms:


Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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