AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 3PHOENYCS FLYNCT06617325

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

A Phase 3 study testing DZP in people with Systemic Lupus Erythematosus, run by UCB Biopharma SRL at 242 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
DZP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
242 sitesin 23 countries
Study dates
21 Nov 2024to 31 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
  • Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:
  • Diagnosed with SLE at least 24 weeks before the Screening Visit 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 at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 <lower limit of normal (LLN) OR complement C4 <LLN 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:
  • Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)
  • Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
  • Historical evidence for anti-dsDNA antibodies
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  • Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) 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 the Screening Visit AND
  • SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:
  • Antimalarial treatment in combination with glucocorticoids and/or immunosuppressants or as stand-alone treatment if justified OR
  • Treatment with glucocorticoids and/or immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)

Who cannot join

  • Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric 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. This includes systemic reactions due to latex allergy
  • Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection [eg, curettage, electrodesiccation] not later than 4 weeks prior to the Screening Visit [V1]), basal cell carcinoma, or dermatological squamous cell carcinoma
  • Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
  • Study participant has 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
  • Study participant has clinically significant active or latent infection
Show all 12Show fewer
  • Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection
  • Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
  • Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol
  • Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
  • Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP
  • Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit

Trial locations and contacts

242 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

UCB Cares contact

1-844-599-2273

ucbcares@ucb.com

UCB Cares contact

001 844 599 2273

242 sites in 23 countries

United States63 sites, 62 recruiting

  • Sl0044 50719

    Aurora, Colorado, 80045

    Recruiting

  • Sl0044 50058

    Avondale, Arizona, 85392

    Recruiting

  • Sl0044 50023

    Baton Rouge, Louisiana, 70836

    Recruiting

  • Sl0044 50738

    Bellaire, Texas, 77401

    Recruiting

  • Sl0044 50737

    Beverly Hills, California, 90210

    Recruiting

  • Sl0044 50775

    Beverly Hills, California, 90211

    Recruiting

  • Sl0044 50239

    Brandon, Florida, 33511

    Recruiting

  • Sl0044 50010

    Brooklyn, New York, 11201

    Recruiting

  • Sl0044 50550

    Chandler, Arizona, 85225

    Recruiting

  • Sl0044 50238

    Charlotte, North Carolina, 28211

    Recruiting

  • Sl0044 50699

    Chicago, Illinois, 60616

    Recruiting

  • Sl0044 50630

    Clearwater, Florida, 33765

    Recruiting

  • Sl0044 50751

    Coral Gables, Florida, 33134

    Recruiting

  • Sl0044 50219

    Detroit, Michigan, 48201

    Recruiting

  • Sl0044 50781

    El Paso, Texas, 79902

    Recruiting

  • Sl0044 50673

    Fort Worth, Texas, 76109

    Recruiting

  • Sl0044 50562

    Frisco, Texas, 75035

    Recruiting

  • Sl0044 50362

    Gainesville, Florida, 32610

    Recruiting

  • Sl0044 50566

    Gainesville, Georgia, 30501-2418

    Recruiting

  • Sl0044 50713

    Gilbert, Arizona, 85297

    Recruiting

  • Sl0044 50662

    Glendale, Arizona, 85306

    Recruiting

  • Sl0044 50773

    Grapevine, Texas, 76051

    Recruiting

  • Sl0044 50766

    Hollywood, Florida, 33024

    Recruiting

  • Sl0044 50688

    Houston, Texas, 77054

    Completed

  • Sl0044 50696

    Houston, Texas, 77090

    Recruiting

  • Sl0044 50723

    Houston, Texas, 77090

    Recruiting

  • Sl0044 50319

    Iowa City, Iowa, 52242.

    Recruiting

  • Sl0044 50001

    Jackson, Tennessee, 38305

    Recruiting

  • Sl0044 50074

    Kansas City, Kansas, 66160

    Recruiting

  • Sl0044 50682

    Kansas City, Missouri, 64151

    Recruiting

  • Sl0044 50257

    La Jolla, California, 92037

    Recruiting

  • Sl0044 50275

    La Palma, California, 90623-1730

    Recruiting

  • Sl0044 50285

    Lake Charles, Louisiana, 70605

    Recruiting

  • Sl0044 50755

    Los Alamitos, California, 90720

    Recruiting

  • Sl0044 50258

    Los Angeles, California, 90022

    Recruiting

  • Sl0044 50586

    Louisville, Kentucky, 40202-5700

    Recruiting

  • Sl0044 50264

    Manhasset, New York, 11030

    Recruiting

  • Sl0044 50718

    Mansfield, Texas, 76063

    Recruiting

  • Sl0044 50763

    Margate, Florida, 33063

    Recruiting

  • Sl0044 50659

    Marietta, Georgia, 30060

    Recruiting

  • Sl0044 50725

    Menifee, California, 92586

    Recruiting

  • Sl0044 50036

    Mesquite, Texas, 75150

    Recruiting

  • Sl0044 50747

    Miami, Florida, 33126

    Recruiting

  • Sl0044 50735

    Miami, Florida, 33155

    Recruiting

  • Sl0044 50681

    Miami, Florida, 33172

    Recruiting

  • Sl0044 50693

    Murfreesboro, Tennessee, 37128

    Recruiting

  • Sl0044 50748

    New Albany, Indiana, 47150

    Recruiting

  • Sl0044 50660

    New Orleans, Louisiana, 70112

    Recruiting

  • Sl0044 50077

    New York, New York, 10021

    Recruiting

  • Sl0044 50262

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Sl0044 50340

    Orange, California, 92868

    Recruiting

  • Sl0044 50052

    Phoenix, Arizona, 85032

    Recruiting

  • Sl0044 50365

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • Sl0044 50324

    Plantation, Florida, 33324

    Recruiting

  • Sl0044 50730

    Rockville, Maryland, 20850

    Recruiting

  • Sl0044 50316

    San Leandro, California, 94578

    Recruiting

  • Sl0044 50677

    Scottsdale, Arizona, 85258

    Recruiting

  • Sl0044 50670

    Searcy, Arkansas, 72143

    Recruiting

  • Sl0044 50061

    Spokane Valley, Washington, 99216

    Recruiting

  • Sl0044 50241

    Syracuse, New York, 13210

    Recruiting

  • Sl0044 50698

    Tampa, Florida, 33618

    Recruiting

  • Sl0044 50717

    Willowbrook, Illinois, 60527

    Recruiting

  • Sl0044 50585

    Winter Park, Florida, 32789

    Recruiting

Other trials in United States

China36 sites, 35 recruiting

  • Sl0044 20293

    Baotou

    Recruiting

  • Sl0044 20128

    Beijing

    Recruiting

  • Sl0044 20157

    Beijing

    Recruiting

  • Sl0044 20173

    Beijing

    Recruiting

  • Sl0044 20201

    Bengbu

    Recruiting

  • Sl0044 20291

    Changchun

    Recruiting

  • Sl0044 20342

    Changchun

    Recruiting

  • Sl0044 20295

    Changsha

    Recruiting

  • Sl0044 20186

    Changzhou

    Recruiting

  • Sl0044 20137

    Chengdu

    Recruiting

  • Sl0044 20019

    Guangzhou

    Recruiting

  • Sl0044 20360

    Guangzhou

    Recruiting

  • Sl0044 20290

    Guilin

    Recruiting

  • Sl0044 20271

    Haikou

    Recruiting

  • Sl0044 20296

    Hangzhou

    Recruiting

  • Sl0044 20185

    Jinan

    Recruiting

  • Sl0044 20364

    Jiujiang

    Recruiting

  • Sl0044 20192

    Nanchang

    Recruiting

  • Sl0044 20024

    Nanjing

    Recruiting

  • Sl0044 20331

    Nanning

    Recruiting

  • Sl0044 20272

    Pingxiang

    Recruiting

  • Sl0044 20020

    Shanghai

    Recruiting

  • Sl0044 20172

    Shanghai

    Recruiting

  • Sl0044 20346

    Shantou

    Recruiting

  • Sl0044 20363

    Shijiazhuang

    Recruiting

  • Sl0044 20204

    Suzhou

    Recruiting

  • Sl0044 20136

    Tianjin

    Recruiting

  • Sl0044 20275

    Urumuqi

    Recruiting

  • Sl0044 20025

    Wenzhou

    Recruiting

  • Sl0044 20180

    Wuhan

    Recruiting

  • Sl0044 20270

    Wuhan

    Recruiting

  • Sl0044 20274

    Xi'an

    Recruiting

  • Sl0044 20341

    Xiamen

    Recruiting

  • Sl0044 20273

    Yangzhou

    Recruiting

  • Sl0044 20132

    Zhengzhou

    Active, not recruiting

  • Sl0044 20361

    Zhuzhou

    Recruiting

Other trials in China

Japan31 sites, 29 recruiting

  • Sl0044 20035

    Bunkyō City

    Recruiting

  • Sl0044 20196

    Bunkyō City

    Recruiting

  • Sl0044 20279

    Bunkyō City

    Recruiting

  • Sl0044 20030

    Chūōku

    Recruiting

  • Sl0044 20281

    Fukuoka

    Recruiting

  • Sl0044 20039

    Kawagoe

    Recruiting

  • Sl0044 20365

    Kawasaki-shi

    Recruiting

  • Sl0044 20045

    Kita-gun

    Recruiting

  • Sl0044 20065

    Kitakyushu

    Recruiting

  • Sl0044 20301

    Kurashiki

    Active, not recruiting

  • Sl0044 20369

    Kyoto

    Recruiting

  • Sl0044 20069

    Meguro-ku

    Recruiting

  • Sl0044 20071

    Nagasaki

    Recruiting

  • Sl0044 20287

    Nagoya

    Recruiting

  • Sl0044 20368

    Osaka

    Recruiting

  • Sl0044 20084

    Saga

    Recruiting

  • Sl0044 20283

    Sagamihara

    Recruiting

  • Sl0044 20031

    Sapporo

    Recruiting

  • Sl0044 20042

    Sasebo

    Recruiting

  • Sl0044 20171

    Sendai

    Active, not recruiting

  • Sl0044 20070

    Shinjuku-ku

    Recruiting

  • Sl0044 20076

    Shinjuku-ku

    Recruiting

  • Sl0044 20285

    Shinjuku-ku

    Recruiting

  • Sl0044 20288

    Shinjuku-ku

    Recruiting

  • Sl0044 20277

    Suita

    Recruiting

  • Sl0044 20032

    Suita-shi

    Recruiting

  • Sl0044 20371

    Toyoake-shi

    Recruiting

  • Sl0044 20278

    Tsu

    Recruiting

  • Sl0044 20358

    Wakayama

    Recruiting

  • Sl0044 20370

    Yokohama

    Recruiting

  • Sl0044 20276

    Yoshida-gun

    Recruiting

Other trials in Japan

Spain15 sites, 15 recruiting

  • Sl0044 40045

    A Coruña

    Recruiting

  • Sl0044 40826

    Badajoz

    Recruiting

  • Sl0044 40159

    Barcelona

    Recruiting

  • Sl0044 40160

    Barcelona

    Recruiting

  • Sl0044 40839

    Castellon

    Recruiting

  • Sl0044 40857

    Madrid

    Recruiting

  • Sl0044 40341

    Málaga

    Recruiting

  • Sl0044 40521

    Mérida

    Recruiting

  • Sl0044 40101

    Sabadell

    Recruiting

  • Sl0044 40617

    Santander

    Recruiting

  • Sl0044 40853

    Santiago de Compostela

    Recruiting

  • Sl0044 40049

    Seville

    Recruiting

  • Sl0044 40103

    Seville

    Recruiting

  • Sl0044 40106

    Seville

    Recruiting

  • Sl0044 40863

    Vitoria-Gasteiz

    Recruiting

Other trials in Spain

Germany14 sites, 12 recruiting

  • Sl0044 40480

    Berlin

    Recruiting

  • Sl0044 40386

    Cologne

    Recruiting

  • Sl0044 40716

    Cologne

    Recruiting

  • Sl0044 40322

    Dessau

    Withdrawn

  • Sl0044 40356

    Dresden

    Recruiting

  • Sl0044 40072

    Freiburg im Breisgau

    Recruiting

  • Sl0044 40717

    Greifswald

    Recruiting

  • Sl0044 40027

    Herne

    Recruiting

  • Sl0044 40139

    Jena

    Active, not recruiting

  • Sl0044 40078

    Leipzig

    Recruiting

  • Sl0044 40854

    Mainz

    Recruiting

  • Sl0044 40815

    München

    Recruiting

  • Sl0044 40402

    Tübingen

    Recruiting

  • Sl0044 40715

    Vogelsang-gommern

    Recruiting

Other trials in Germany

Italy11 sites, 11 recruiting

  • Sl0044 40816

    Brescia

    Recruiting

  • Sl0044 40514

    Genova

    Recruiting

  • Sl0044 40291

    Milan

    Recruiting

  • Sl0044 40471

    Milan

    Recruiting

  • Sl0044 40509

    Padova

    Recruiting

  • Sl0044 40176

    Pisa

    Recruiting

  • Sl0044 40148

    Roma

    Recruiting

  • Sl0044 40675

    Roma

    Recruiting

  • Sl0044 40860

    Roma

    Recruiting

  • Sl0044 40897

    Roma

    Recruiting

  • Sl0044 40830

    Rozzano

    Recruiting

Other trials in Italy

Poland11 sites, 11 recruiting

  • Sl0044 40398

    Katowice

    Recruiting

  • Sl0044 40795

    Katowice

    Recruiting

  • Sl0044 40502

    Krakow

    Recruiting

  • Sl0044 40037

    Lublin

    Recruiting

  • Sl0044 40044

    Poznan

    Recruiting

  • Sl0044 40484

    Poznan

    Recruiting

  • Sl0044 40821

    Poznan

    Recruiting

  • Sl0044 40097

    Warsaw

    Recruiting

  • Sl0044 40098

    Warsaw

    Recruiting

  • Sl0044 40397

    Wroclaw

    Recruiting

  • Sl0044 40481

    Wroclaw

    Recruiting

Other trials in Poland

Taiwan8 sites, 8 recruiting

  • Sl0044 20330

    New Taipei City

    Recruiting

  • Sl0044 20080

    Taichung

    Recruiting

  • Sl0044 20113

    Taichung

    Recruiting

  • Sl0044 20142

    Taichung

    Recruiting

  • Sl0044 20086

    Taipei

    Recruiting

  • Sl0044 20099

    Taipei

    Recruiting

  • Sl0044 20362

    Taipei

    Recruiting

  • Sl0044 20082

    Taiyuan

    Recruiting

Other trials in Taiwan

Argentina7 sites, 7 recruiting

  • Sl0044 60004

    C.a.b.a

    Recruiting

  • Sl0044 60002

    Capital Federal

    Recruiting

  • Sl0044 60024

    Córdoba

    Recruiting

  • Sl0044 60029

    Mendoza

    Recruiting

  • Sl0044 60003

    Quilmes

    Recruiting

  • Sl0044 60011

    San Juan

    Recruiting

  • Sl0044 60014

    San Miguel de Tucumán

    Recruiting

Other trials in Argentina

United Kingdom7 sites, 7 recruiting

  • Sl0044 40847

    Bath

    Recruiting

  • Sl0044 40858

    Belfast

    Recruiting

  • Sl0044 40281

    Leeds

    Recruiting

  • Sl0044 40113

    London

    Recruiting

  • Sl0044 40864

    Newcastle upon Tyne

    Recruiting

  • Sl0044 40701

    Sheffield

    Recruiting

  • Sl0044 40725

    West Bromwich

    Recruiting

Other trials in United Kingdom

South Korea6 sites, 6 recruiting

  • Sl0044 20141

    Busan

    Recruiting

  • Sl0044 20108

    Incheon

    Recruiting

  • Sl0044 20104

    Seoul

    Recruiting

  • Sl0044 20105

    Seoul

    Recruiting

  • Sl0044 20351

    Seoul

    Recruiting

  • Sl0044 20092

    Suwon

    Recruiting

Other trials in South Korea

Denmark4 sites, 4 recruiting

  • Sl0044 40903

    Aalborg

    Recruiting

  • Sl0044 40562

    Aarhus

    Recruiting

  • Sl0044 40513

    Copenhagen

    Recruiting

  • Sl0044 40489

    Odense

    Recruiting

Other trials in Denmark

Greece4 sites, 4 recruiting

  • Sl0044 40376

    Athens

    Recruiting

  • Sl0044 40501

    Athens

    Recruiting

  • Sl0044 40377

    Heraklion

    Recruiting

  • Sl0044 40507

    Larissa

    Recruiting

Other trials in Greece

Serbia4 sites, 4 recruiting

  • Sl0044 40730

    Belgrade

    Recruiting

  • Sl0044 40466

    Kragujevac

    Recruiting

  • Sl0044 40861

    Niška Banja

    Recruiting

  • Sl0044 40392

    Novi Sad

    Recruiting

Other trials in Serbia

Canada3 sites, 3 recruiting

  • Sl0044 50771

    Québec

    Recruiting

  • Sl0044 50259

    Rimouski

    Recruiting

  • Sl0044 50045

    Toronto

    Recruiting

Other trials in Canada

France3 sites, 3 recruiting

  • Sl0044 40896

    Bordeaux

    Recruiting

  • Sl0044 40848

    Le Mans

    Recruiting

  • Sl0044 40506

    Montpellier

    Recruiting

Other trials in France

Mexico3 sites, 3 recruiting

  • Sl0044 50250

    Cuernavaca

    Recruiting

  • Sl0044 50694

    Guadalajara

    Recruiting

  • Sl0044 50695

    Mexico City

    Recruiting

Other trials in Mexico

Netherlands3 sites, 3 recruiting

  • Sl0044 40838

    Amsterdam

    Recruiting

  • Sl0044 40292

    Groningen

    Recruiting

  • Sl0044 40565

    Maastricht

    Recruiting

Other trials in Netherlands

Puerto Rico3 sites, 3 recruiting

  • Sl0044 50671

    Caguas

    Recruiting

  • Sl0044 50683

    San Juan

    Recruiting

  • Sl0044 50767

    San Juan

    Recruiting

Other trials in Puerto Rico

Belgium2 sites, 2 recruiting

  • Sl0044 40002

    Leuven

    Recruiting

  • Sl0044 40060

    Liège

    Recruiting

Other trials in Belgium

Peru2 sites, 1 recruiting

  • Sl0044 60026

    Arequipa

    Withdrawn

  • Sl0044 60009

    Surco

    Recruiting

Other trials in Peru

Chile1 site, 1 recruiting

  • Sl0044 60018

    Santiago

    Recruiting

Other trials in Chile

United Arab Emirates1 site, 1 recruiting

  • Sl0044 40908

    Dubai

    Recruiting

Other trials in United Arab Emirates

About this study

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

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.

Being tested
DZP, Placebo
Keywords
Systemic lupus erythematosus, Dapirolizumab pegol, SLE, DZP
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DZPDrug

    Also called CDP7657

    Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.

  • PlaceboOther

    Also called PBO

    Study participants will receive placebo at prespecified time-points.

Study groups in NCT06617325
Study groupRoleWhat they receive
Dapirolizumab pegolExperimentalStudy participants will receive dapriolizumab pegol throughout the Treatment Period.
Receives: Drug: DZP
PlaceboPlacebo comparatorStudy participants will receive placebo throughout the Treatment Period.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48

    A study participant is a BICLA responder if all of the following is fulfilled: a. BILAG 2004 improvement without worsening, defined as BILAG 2004 Grade As at Baseline improved to B/C/D, BILAG 2004 Grade Bs at Baseline improved to C/D, and no BILAG 2004 worsening in other BILAG 2004 organ systems (that had BILAG 2004 Grade C/D/E at Baseline) such that there are no new BILAG 2004 Grades A nor greater than 1 new BILAG 2004 Grade(s) B; and b. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI- 2K) total score compared to Baseline (defined as no increase in SLEDAI-2K total score); and c. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline defined as ≤10 mm increase on a 100 mm 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.

    Measured: Week 48

Secondary outcomes (14)

  1. Achievement of SRI 4 response at Week 48

    The Systemic Lupus Erythematosus Responder Index-4 (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 Baseline score; "no worsening" is defined as either no worsening or worsening <10% of the full 100 mm visual analog scale (VAS).

    Measured: Week 48

  2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48

    Severe BILAG flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse qualifying for the Grade A.

    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.

    Measured: Week 48

  3. Achievement of LLDAS at Week 40 and maintaining LLDAS at Weeks 44 and 48

    Low lupus disease activity state (LLDAS) is defined as:

    • No significant disease activity as per Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); 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
    • Physician's Global Assessment of Disease (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

    Measured: Week 40 to Week 48

  4. Change from Baseline to Week 48 in the FATIGUE-PRO Total score

    The FATIGUE-PRO (Fatigue patient-reported outcome) is a PRO instrument measuring fatigue, a core symptom of SLE, developed using qualitative and quantitative research conducted in patients with SLE. It is composed of 31 items covering 3 domains: Physical Fatigue (items 1-9), Mental and Cognitive Fatigue (items 10-20), and Susceptibility to Fatigue (items 21-31). The study participant is asked to score each fatigue item based on how frequently they experienced the item during the past 7 days using the following response options: 1=none of the time; 2=a little of the time; 3=some of the time; 4=most of the time; 5=all of the time.

    Measured: From Baseline to Week 48

  5. Percentage of participants having a reduction in glucocorticoid dose from >7.5mg/day prednisone-equivalent dose at Baseline to ≤7.5mg/day at Week 36 and maintained through Week 48

    The achievement of a reduction in glucocorticoid dose from >7.5mg/day prednisone equivalent dose at Baseline to ≤7.5mg/day prednisone equivalent at Week 36 and maintained through Week 48 will be assessed.

    Measured: From Baseline to Week 48

  6. Achievement of BILAG 2004 improvement without worsening at Week 48

    BILAG 2004 improvement without worsening can be defined as 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.

    Measured: Week 48

  7. Change from Baseline in PGA at Week 48

    Physician's Global Assessment of Disease (PGA), the investigator will rate the overall status of the study participant. The PGA of disease activity used will be a 100 mm linear scale without anchors. The very far left end is 'very good, asymptomatic and no limitation of normal activities'; the very far right end indicates 'severe disease'.

    Measured: From Baseline to Week 48

  8. Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48

    A BILAG severe flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse qualifying for the Grade A. 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.

    A 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. 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.

    Measured: During Treatment Period up to Week 48

  9. Change from Baseline in SLEDAI-2K at Week 48

    SLEDAI-2K measures disease activity. Disease activity in the 30 days prior to and at the time point of the assessment shall be considered. 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.

    Measured: From Baseline to Week 48

  10. Change from Baseline in FACIT-Fatigue score at Week 48

    The FACIT (Functional Assessment of Chronic Illness Therapy)-Fatigue scale is a patient-reported outcome (PRO) measure assessing symptoms and impacts of fatigue originally developed in patients with cancer (Cella et al, 2002). It is composed of 13 items, all scored from 0 (Not at all) to 4 (Very much), and uses a recall period of the past 7 days. The FACIT-Fatigue score ranges from 0 to 52 with 0 being the worst possible score and 52 being the best possible score (lowest level of fatigue). To obtain a score from 0 to 52, all negatively worded questions have to be recoded, so that responses range from worst (0) to the best (4) outcome.

    Measured: From Baseline to Week 48

  11. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.

    Measured: From Baseline until Safety Follow-Up (up to Week 54)

  12. Percentage of participants with serious treatment-emergent adverse events during the study

    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

    1. Results in death
    2. Is life-threatening
    3. Requires inpatient hospitalization or prolongation of existing hospitalization
    4. Results in persistent disability/incapacity
    5. Is a congenital anomaly/birth defect
    6. Is an Important medical event

    Measured: From Baseline until Safety Follow-Up (up to Week 54)

  13. Percentage of participants with treatment-emergent adverse events of special interest during the study

    An adverse event of special interest is any adverse event (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.

    Measured: From Baseline until Safety Follow-Up (up to Week 54)

  14. Percentage of participants with treatment-emergent adverse events of special monitoring during the study

    An adverse event of special monitoring is a product-specific adverse event (AE), adverse reaction, or safety topic considered as requiring special monitoring by UCB.

    Measured: From Baseline until Safety Follow-Up (up to Week 54)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start21 Nov 2024
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06617325
Sponsor's protocol ID
SL0044
Other IDs
2019-003407-35, 2023-508191-11, U1111-1298-3467, 2023, 2019
Acronym
PHOENYCS FLY
Status last verified
Oct 2026
First submitted
24 Sep 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DZP in people with Systemic Lupus Erythematosus, run by UCB Biopharma SRL at 242 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 242 sites in United States, China, Japan, Spain, Germany and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact UCB Cares (1-844-599-2273, ucbcares@ucb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06617325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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