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Trial record 1 of 1 for:    NCT04294667
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A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04294667
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief Summary:
The purpose of this study is to 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: DZP Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Dapirolizumab pegol
Subjects will receive dapriolizumab pegol througout the Treatment Period.
Drug: DZP
Subjects will receive dapirolizumab pegol at prespecified time-points.
Other Name: CDP7657

Placebo Comparator: Placebo
Subjects will receive placebo througout the Treatment Period.
Other: Placebo
Subjects will receive placebo at prespecified time-points.
Other Name: PBO




Primary Outcome Measures :
  1. Achievement of BICLA response at Week 48 [ Time Frame: Week 48 ]

    A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled:

    1. 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
    2. 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
    3. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10mm increase on a 100mm visual analog scale

    Escape treatment intervention as indicated by Investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.



Secondary Outcome Measures :
  1. Achievement of BICLA response at Week 24 [ Time Frame: Week 24 ]

    A study participant is considered to be a BICLA responder if all of the following is fulfilled:

    1. 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
    2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
    3. No worsening in the PGA compared to Baseline Visit defined as ≤10mm increase on a 100mm visual analog scale

    Escape treatment intervention as indicated by Investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.


  2. Achievement of BICLA response at Week 12 [ Time Frame: Week 12 ]

    A study participant is considered to be a BICLA responder if all of the following is fulfilled:

    1. 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
    2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
    3. No worsening in the PGA compared to Baseline Visit defined as ≤10mm increase on a 100mm visual analog scale

    Escape treatment intervention as indicated by Investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.


  3. Achievement of prevention of severe BILAG flares through Week 48 [ Time Frame: Week 48 ]
    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).

  4. Achievement of LLDAS in ≥50% of post-Baseline visits through Week 48 [ Time Frame: Week 48 ]

    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, 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 ≤33mm
    • Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5mg per day
    • Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol

  5. Change from Baseline in SLEDAI-2K at Week 48 [ Time Frame: From Baseline (Day 1) to Week 48 ]
    The SLEDAI-2K Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K; 30 days) measures disease activity. It is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The total score falls between 0 and 105, with higher scores representing increased disease activity.

  6. Achievement of BILAG improvement without worsening at Week 48 [ Time Frame: Week 48 ]

    The British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) grading is anchored in the physician's intention to treat. Disease activity is graded separately for 9 body systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, hematology) to 5 different grades (A to E) as follows:

    A ("Active") = Severely active disease B ("Beware") = Moderately active disease C ("Contentment") = Mild stable disease D ("Discount") = Inactive now but previously active E ("Excluded") = Never affected


  7. Change from Baseline in PGA at Week 48 [ Time Frame: From Baseline (Day 1) to Week 48 ]

    Physician's Global Assessment of Disease (PGA)

    The Investigator will rate the overall status of the study participant in response to the following statement:

    "Please mark a vertical line on the scale below to assess the overall status of the study participant's Systemic Lupus Erythematosus signs and symptoms and the functional capacity of the study participant. The very far left end is 'very good, asymptomatic and no limitation of normal activities'; the very far right end indicates 'severe disease' . This refers to the most severe possible disease, and does not reflect the most severe ever seen in a particular patient, but the most severe disease ever seen in all SLE patients." When scoring the PGA, the assessor should always look back at the score from the previous visit.


  8. Achievement of SRI4 response at Week 48 [ Time Frame: Week 48 ]

    The Systemic Lupus Erythematosus Responder Index (SRI)-4 define responders as (ie, all criteria must be met):

    • Reduction in SLEDAI-2K score of ≥4
    • No shift from BILAG 2004 Grade B, C, D, or E to A post-Baseline
    • No more than 1 shift from BILAG 2004 Grade C, D, or E to B post-Baseline
    • No worsening in the PGA compared to study entry defined as ≤10mm increase on a 100mm visual analog scale

  9. Achievement of prevention of moderate/severe BILAG flares through Week 48 [ Time Frame: Week 48 ]

    BILAG severe flare is defined as a new 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).

    BILAG moderate flare is defined as 2 or more BILAG 2004 Grade Bs due to individual items that are new or worse since previous visit and are qualifying for the Grade B in any system (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade B will be according to the supplementary information for the numerical scoring of the BILAG- 2004 index (Yee et al, 2010)


  10. Time to severe BILAG Flare through Week 48 [ Time Frame: During Treatment Period up to Week 48 ]
    BILAG severe flare is defined as a new 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).

  11. Time to moderate/severe BILAG flare through Week 48 [ Time Frame: During Treatment Period up to Week 48 ]

    BILAG severe flare is defined as a new 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).

    BILAG moderate flare is defined as 2 or more BILAG 2004 Grade Bs due to individual items that are new or worse since previous visit and are qualifying for the Grade B in any system (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade B will be according to the supplementary information for the numerical scoring of the BILAG- 2004 index (Yee et al, 2010)


  12. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54) ]
    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.

  13. Percentage of participants with serious treatment-emergent adverse events during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54) ]

    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
    • Is a congenital anomaly or birth defect
    • Is an infection that requires treatment with parenteral antibiotics
    • 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

  14. Percentage of participants with treatment-emergent adverse events of special interest during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54) ]
    An adverse event of special interest is any AE that a regulatory authority has mandated be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound.

  15. Percentage of participants with treatment-emergent adverse events of special monitoring during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 54) ]
    An adverse event of special monitoring is a product-specific AEs, adverse reactions, or safety topics considered as requiring special monitoring by UCB.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Study participant must be ≥16 years of age
  • Study participants who have moderate to severe disease activity due to either 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:

    1. Diagnosed with SLE at least 24 weeks before study entry by a qualified physician
    2. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
    3. 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 <LLN OR elevated erythrocyte-bound complement C4d as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:

    1. Anti-Smith (anti-Sm) antibodies (central laboratory)
    2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
    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 ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND
  • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at Screening Visit AND
  • SLEDAI-2K without labs ≥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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294667


Contacts
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Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations
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Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04294667    
Other Study ID Numbers: SL0043
2019-003406-27 ( EudraCT Number )
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study 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 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.clinicalstudydatarequest.com 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. This plan may change if a determination is made that the data cannot be adequately anonymized.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data from this study 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.
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.clinicalstudydatarequest.com 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.
URL: http://clinicalstudydatarequest.com

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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
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Systemic lupus erythematosus
Dapirolizumab pegol
SLE
DZP
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases