A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 16 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests dapirolizumab pegol (DZP) added to usual lupus medicines. It looks at whether DZP is safe and can improve moderate to severe systemic lupus erythematosus (SLE) over time. It is for people whose lupus stays active or often flares up despite steady treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be at least 16 years old, or at least 18 in China. Local rules may set other age limits.
- A qualified doctor must have diagnosed your lupus at least 24 weeks before screening.
- Your lupus must meet the study’s diagnosis rules, and blood tests must show signs of lupus.
- Your lupus must still be moderately to severely active despite steady doses of usual lupus medicines.
- Your lupus must meet the study’s disease activity scores at screening and at the start of treatment.
- You must take stable doses of an antimalarial medicine used for lupus, alone if justified or with steroids or medicines that lower immune activity. If antimalarials are not suitable or available, you must take steroids and/or medicines that lower immune activity.
Who can't join
- You have a physical or mental health condition that the study doctor thinks could make joining unsafe or difficult, including a life-threatening condition.
- You have had a severe allergic reaction to injected contrast dye, human or mouse proteins, or antibody medicines, or a whole-body reaction to latex.
- You have had cancer, except certain treated cancers: fully removed early cervical cancer at least 4 weeks before screening, basal cell skin cancer, or squamous cell skin cancer.
- You have mixed connective tissue disease, scleroderma (a disease that can harden skin), or either of these together with lupus.
- You have HIV, HTLV-1 infection, or certain immune system deficiencies. You also cannot have a significant active or inactive infection, a recent infection that returned or took advantage of weak immunity, or ongoing treatment to keep such an infection from returning. The recent-infection limit is 12 weeks before the first dose.
- You received a live or weakened-live vaccine within 6 weeks before the first dose, or took medicines not allowed within the study’s required waiting period.
- You were previously assigned to this study or to DZP treatment in another study. You also cannot be in another study of an experimental drug or have joined one too recently: within 12 weeks or 5 drug half-lives, whichever is longer.
- At screening, you have stage 4 kidney failure, a kidney filtering rate below 30, blood creatinine above 2.5 mg/dL, urine protein above 3 grams per day, or a urine protein-to-creatinine ratio above 340 mg/mmol. These tests measure kidney function and protein leaking into urine.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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: a. 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: 1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history) 2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory) 3. Historical evidence for anti-dsDNA antibodies 4. 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) Exclusion Criteria: * 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 * 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
Study sites (63)
AR
- Sl0044 50670 · Searcy, AR 72143More trials in Searcy
AZ
- Sl0044 50058 · Avondale, AZ 85392More trials in Avondale
- Sl0044 50550 · Chandler, AZ 85225More trials in Chandler
- Sl0044 50713 · Gilbert, AZ 85297More trials in Gilbert
- Sl0044 50662 · Glendale, AZ 85306More trials in Glendale
- Sl0044 50052 · Phoenix, AZ 85032More trials in Phoenix
- Sl0044 50677 · Scottsdale, AZ 85258More trials in Scottsdale
CA
- Sl0044 50737 · Beverly Hills, CA 90210More trials in Beverly Hills
- Sl0044 50775 · Beverly Hills, CA 90211More trials in Beverly Hills
- Sl0044 50257 · La Jolla, CA 92037More trials in La Jolla
- Sl0044 50275 · La Palma, CA 90623-1730More trials in La Palma
- Sl0044 50755 · Los Alamitos, CA 90720More trials in Los Alamitos
- Sl0044 50258 · Los Angeles, CA 90022More trials in Los Angeles
- Sl0044 50725 · Menifee, CA 92586More trials in Menifee
- Sl0044 50340 · Orange, CA 92868More trials in Orange
- Sl0044 50316 · San Leandro, CA 94578More trials in San Leandro
CO
- Sl0044 50719 · Aurora, CO 80045More trials in Aurora
FL
- Sl0044 50239 · Brandon, FL 33511More trials in Brandon
- Sl0044 50630 · Clearwater, FL 33765More trials in Clearwater
- Sl0044 50751 · Coral Gables, FL 33134More trials in Coral Gables
- Sl0044 50362 · Gainesville, FL 32610More trials in Gainesville
- Sl0044 50766 · Hollywood, FL 33024More trials in Hollywood
- Sl0044 50763 · Margate, FL 33063More trials in Margate
- Sl0044 50747 · Miami, FL 33126More trials in Miami
- Sl0044 50735 · Miami, FL 33155More trials in Miami
- Sl0044 50681 · Miami, FL 33172More trials in Miami
- Sl0044 50324 · Plantation, FL 33324More trials in Plantation
- Sl0044 50698 · Tampa, FL 33618More trials in Tampa
- Sl0044 50585 · Winter Park, FL 32789More trials in Winter Park
GA
- Sl0044 50566 · Gainesville, GA 30501-2418More trials in Gainesville
- Sl0044 50659 · Marietta, GA 30060More trials in Marietta
IA
- Sl0044 50319 · Iowa City, IA 52242.More trials in Iowa City
IL
- Sl0044 50699 · Chicago, IL 60616More trials in Chicago
- Sl0044 50717 · Willowbrook, IL 60527More trials in Willowbrook
IN
- Sl0044 50748 · New Albany, IN 47150More trials in New Albany
KS
- Sl0044 50074 · Kansas City, KS 66160More trials in Kansas City
KY
- Sl0044 50586 · Louisville, KY 40202-5700More trials in Louisville
LA
- Sl0044 50023 · Baton Rouge, LA 70836More trials in Baton Rouge
- Sl0044 50285 · Lake Charles, LA 70605More trials in Lake Charles
- Sl0044 50660 · New Orleans, LA 70112More trials in New Orleans
MD
- Sl0044 50730 · Rockville, MD 20850More trials in Rockville
MI
- Sl0044 50219 · Detroit, MI 48201More trials in Detroit
MO
- Sl0044 50682 · Kansas City, MO 64151More trials in Kansas City
NC
- Sl0044 50238 · Charlotte, NC 28211More trials in Charlotte
NY
- Sl0044 50010 · Brooklyn, NY 11201More trials in Brooklyn
- Sl0044 50264 · Manhasset, NY 11030More trials in Manhasset
- Sl0044 50077 · New York, NY 10021More trials in New York
- Sl0044 50241 · Syracuse, NY 13210More trials in Syracuse
OK
- Sl0044 50262 · Oklahoma City, OK 73104More trials in Oklahoma City
PA
- Sl0044 50365 · Pittsburgh, PA 15213More trials in Pittsburgh
TN
- Sl0044 50001 · Jackson, TN 38305More trials in Jackson
- Sl0044 50693 · Murfreesboro, TN 37128More trials in Murfreesboro
TX
- Sl0044 50738 · Bellaire, TX 77401More trials in Bellaire
- Sl0044 50781 · El Paso, TX 79902More trials in El Paso
- Sl0044 50673 · Fort Worth, TX 76109More trials in Fort Worth
- Sl0044 50562 · Frisco, TX 75035More trials in Frisco
- Sl0044 50773 · Grapevine, TX 76051More trials in Grapevine
- Sl0044 50688 · Houston, TX 77054More trials in Houston
- Sl0044 50696 · Houston, TX 77090More trials in Houston
- Sl0044 50723 · Houston, TX 77090More trials in Houston
- Sl0044 50718 · Mansfield, TX 76063More trials in Mansfield
- Sl0044 50036 · Mesquite, TX 75150More trials in Mesquite
WA
- Sl0044 50061 · Spokane Valley, WA 99216More trials in Spokane Valley