Ended Therapeutic exploratory (Phase II) Systemic Lupus Erythematosus

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (PLUTO)

EU CTIS ID: 2024-512730-15-00

What this study is testing

"Evaluate the efficacy of belimumab in the pediatric SLE population. Evaluate the pharmacokinetics of belimumab in the pediatric SLE population. Evaluate the safety and tolerability of belimumab in the pediatric SLE population. Evaluate the effects of belimumab on the quality of life in the pediatric SLE population. "

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Are 5 to 17 years of age.
  • Have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE.
  • Have active SLE disease defined as a SELENA SLEDAI score ≥ 6 at screening.
  • "Have unequivocally positive autoantibody test results defined as an ANA titre ≥ 1:80 and/or a positive anti-dsDNA (≥ 30 IU/mL) serum antibody test from 2 independent time points as follows: - Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results. OR - One positive historical test result and 1 positive test result during the screening period. Historical documentation of a positive test of ANA (e.g., ANA by HEp-2 titre) or anti-dsDNA (e.g., anti-dsDNA by Farr assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive vs negative OR negative, equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted."
  • "Are on a stable SLE treatment regimen. "" Stable treatment at baseline"" consists of any of the following medications (alone or in combination) at a fixed dose for a period of at least 30 days prior to Day 0: - Corticosteroids (prednisone or prednisone equivalent up to 0.5 mg/kg/day): -For subjects on SLE combination therapy, their stable steroid dose must be fixed within the range of 0 to 0.5mg/kg/day (prednisone or prednisone equivalent) - For subjects whose only SLE treatment is steroids, their stable steroid dose must be fixed within the range of 0.1-0.5mg/kg/day. - For those subjects on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose. - Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine or thalidomide. - Anti-malarials (e.g. hydroxychloroquine, chloroquine, quinacrine) - Non-steroidal anti-inflammatory drugs (NSAIDs) Note: - Pre-existing SLE medications must be stable for at least 30 days prior to Day 0. - Corticosteroids may be added as new medications or their doses adjusted only up to 30 days prior to Day 0. - New SLE therapy other than corticosteroids must not be added within 60 days of Day 0. "
  • "A sexually active female subject is eligible to enter the study if she is: - Not pregnant or nursing; - Of non-childbearing potential. Non-childbearing potential is defined as a premenarcheal female who has not yet entered puberty as evidenced by lack of breast development (palpable glandular breast tissue); or a female who has documentation (medical report verification) of a hysterectomy, has both ovaries surgically removed or tubal ligation; or - Of childbearing potential (i.e., with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes those with oligomenorrhoea [even severe]. These must have a negative serum pregnancy test at screening, and agree to 1 of the following: Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent; or Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent and 16 weeks after the last dose of study agent: - Implants of levonorgestrel or etonogestrel; - Ethinyl estradiol/Etonogestrel vaginal ring; - Injectable progesterone; - Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; - Oral contraceptives (either combined or progesterone only); - Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; - Transdermal contraceptive patch; - Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject. Note: Mycophenolate mofetil (MMF) and other forms of mycophenolate affect the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving mycophenolate who are using oral contraceptives for birth control should employ an additional method (eg, barrier method)."

You likely can't join if

  • Have received treatment with belimumab (BENLYSTA™) at any time.
  • Have received intravenous (IV) cyclophosphamide within 60 days of Day 0.
  • "Have received any of the following within 90 days of Day 0: - Anti-TNF therapy (e.g., adalimumab, etanercept, infliximab). - Interleukin-1 receptor antagonist (anakinra). - Intravenous immunoglobulin (IVIG). - Plasmapheresis."
  • "Have received any of the following within 60 days of Day 0: - A non-biologic investigational agent. - Any new immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, (See Inclusion Criteria #5) Note: New inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed. Any NSAID use for less than 1 week is allowed. - High dose prednisone or equivalent (> 1.5 mg/kg/day) or any steroid injection (intramuscular, intraarticular or intravenous). "
  • "Have received any of the following within 30 days of Day 0: - A live vaccine. - A change in dose of a corticosteroid, other immunosuppressive/ immunomodulatory agent, anti-malarial, NSAID, (See Inclusion Criteria #5)"
  • "Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0."
See the full eligibility criteria
Who can join
  • Are 5 to 17 years of age.
  • Have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE.
  • Have active SLE disease defined as a SELENA SLEDAI score ≥ 6 at screening.
  • "Have unequivocally positive autoantibody test results defined as an ANA titre ≥ 1:80 and/or a positive anti-dsDNA (≥ 30 IU/mL) serum antibody test from 2 independent time points as follows: - Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results. OR - One positive historical test result and 1 positive test result during the screening period. Historical documentation of a positive test of ANA (e.g., ANA by HEp-2 titre) or anti-dsDNA (e.g., anti-dsDNA by Farr assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive vs negative OR negative, equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted."
  • "Are on a stable SLE treatment regimen. "" Stable treatment at baseline"" consists of any of the following medications (alone or in combination) at a fixed dose for a period of at least 30 days prior to Day 0: - Corticosteroids (prednisone or prednisone equivalent up to 0.5 mg/kg/day): -For subjects on SLE combination therapy, their stable steroid dose must be fixed within the range of 0 to 0.5mg/kg/day (prednisone or prednisone equivalent) - For subjects whose only SLE treatment is steroids, their stable steroid dose must be fixed within the range of 0.1-0.5mg/kg/day. - For those subjects on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose. - Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine or thalidomide. - Anti-malarials (e.g. hydroxychloroquine, chloroquine, quinacrine) - Non-steroidal anti-inflammatory drugs (NSAIDs) Note: - Pre-existing SLE medications must be stable for at least 30 days prior to Day 0. - Corticosteroids may be added as new medications or their doses adjusted only up to 30 days prior to Day 0. - New SLE therapy other than corticosteroids must not be added within 60 days of Day 0. "
  • "A sexually active female subject is eligible to enter the study if she is: - Not pregnant or nursing; - Of non-childbearing potential. Non-childbearing potential is defined as a premenarcheal female who has not yet entered puberty as evidenced by lack of breast development (palpable glandular breast tissue); or a female who has documentation (medical report verification) of a hysterectomy, has both ovaries surgically removed or tubal ligation; or - Of childbearing potential (i.e., with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes those with oligomenorrhoea [even severe]. These must have a negative serum pregnancy test at screening, and agree to 1 of the following: Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent; or Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent and 16 weeks after the last dose of study agent: - Implants of levonorgestrel or etonogestrel; - Ethinyl estradiol/Etonogestrel vaginal ring; - Injectable progesterone; - Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; - Oral contraceptives (either combined or progesterone only); - Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; - Transdermal contraceptive patch; - Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject. Note: Mycophenolate mofetil (MMF) and other forms of mycophenolate affect the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving mycophenolate who are using oral contraceptives for birth control should employ an additional method (eg, barrier method)."
  • Subject signs and dates a written age appropriate assent form (in accordance with applicable regulations) and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent (including consent for the use and disclosure of research-related health information) that the subject will comply with the study protocol procedures (including required study visits).
What rules you out
  • Have received treatment with belimumab (BENLYSTA™) at any time.
  • Have received intravenous (IV) cyclophosphamide within 60 days of Day 0.
  • "Have received any of the following within 90 days of Day 0: - Anti-TNF therapy (e.g., adalimumab, etanercept, infliximab). - Interleukin-1 receptor antagonist (anakinra). - Intravenous immunoglobulin (IVIG). - Plasmapheresis."
  • "Have received any of the following within 60 days of Day 0: - A non-biologic investigational agent. - Any new immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, (See Inclusion Criteria #5) Note: New inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed. Any NSAID use for less than 1 week is allowed. - High dose prednisone or equivalent (> 1.5 mg/kg/day) or any steroid injection (intramuscular, intraarticular or intravenous). "
  • "Have received any of the following within 30 days of Day 0: - A live vaccine. - A change in dose of a corticosteroid, other immunosuppressive/ immunomodulatory agent, anti-malarial, NSAID, (See Inclusion Criteria #5)"
  • "Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0."
  • Have required renal replacement therapy (e.g. hemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy
  • Subjects 12 years of age and older who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (Refer to Appendix 12) in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
  • Have a history of a primary immunodeficiency
  • Have an IgA deficiency (IgA level < 10 mg/dL).
  • "Have acute or chronic infections requiring management, as follows: - Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria). - Hospitalization for treatment of infection within 60 days of Day 0. - Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) for infection within 60 days of Day 0."
  • "Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 ml/min."
  • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
  • Have a historically positive HIV test or test positive at screening for HIV.
  • "Hepatitis B: Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs as follows: - Subjects positive for HBsAg are excluded - Subjects negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody are eligible to participate - Subjects negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody will require clarification of their status by testing for HB DNA which if positive will exclude the subject from participation. Subjects with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered negative."
  • Hepatitis C: Positive test for Hepatitis C antibody confirmed on an additional blood sample by RNA PCR assay. Subjects who are positive for Hepatitis C antibody and negative when the Hepatitis C RNA-PCR assay is performed on an additional sample will be eligible to participate. Subjects who are positive for Hepatitis C antibody and have a positive result for the HCV when the Hepatitis C RNA PCR assay is performed on the additional sample will not be eligible to participate. (Institution or country specific guidelines for blood sample volume limits must be followed in collection of the additional blood sample.)
  • "Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed: - Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment. - Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy. - Stable Grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition. - Any grade proteinuria - Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the ALT and or AST must be ≤ Grade 2. - Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE "
  • Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
  • Children in Care: A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The determination of whether a child meets the definition of CiC should be made with the study centre staff in consultation with the responsible IRB/Ethics Committee.
  • "Have acute severe nephritis defined as a significant worsening of renal disease (e.g., the presence of urinary sediments and other lab abnormalities) that, in the opinion of the study investigator, may lead to the subject requiring induction therapy with IV cyclophosphamide, MMF or high dose corticosteroids during the first 6 months of the trial. Note: clinically stable lupus nephritis which can be managed with medications allowed in the study will not exclude subjects from participating in the trial (nor will any maximum level of proteinuria exclude subjects). Clinical assessment and medical management of nephritis will be at the discretion of the study investigator."
  • "Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant."
  • "Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk."
  • "Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study."
  • Have a history of malignant neoplasm within the last 5 years.
  • "Have received any of the following within 364 days of Day 0: - Treatment with any B-cell targeted therapy (e.g., rituximab, other anti- CD20 agents, anti- CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc) - Abatacept. - A biologic investigational agent"
  • Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 364 days of Day 0 (Topical or inhaled steroids are permitted).

The study team makes the final eligibility decision.

Where it's taking place

  • Russian Federation
  • United Kingdom
  • Mexico
  • Japan
  • Argentina
  • Peru
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Russian Federation; United Kingdom; Mexico; Japan; Argentina; Peru and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.