Authorised Therapeutic exploratory (Phase II) Systemic Lupus Erythematosus

A Phase 2 Study of Obexelimab in Patients with Systemic Lupus Erythematosus

EU CTIS ID: 2024-510584-37-00

What this study is testing

To evaluate the efficacy of obexelimab compared to placebo to reduce SLE disease activity.

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

1. ≥ 18 to ≤ 70 years of age.
2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.
3. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.
4. At screening, at least one of the following: a) anti-nuclear antibody (ANA) ≥ 1:80 b) positive anti-dsDNA c) positive anti-Sm
5. Patient has all 3 of the following based on features active on the day of the visits: a) hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1. Note: Clinical points exclude laboratory tests, except proteinuria. Patients with proteinuria scored as present (i.e., urine protein/creatinine > 500 mg/g) at screening will also be scored as present on Day 1 if a dipstick performed at the site on Day 1 is at least 2+ proteinuria. If the urine protein/creatinine > 500 mg/g at screening is not known to be stable based on recent past proteinuria testing, then a repeat urine protein/creatinine measurement is required during the Screening Period. b) BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1. c) In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.
6. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant. The treatment regimen must be as below: a) If taking oral corticosteroid: No increase in dosing regimen during the Screening Period, and at stable dose ≤ 20 mg/day prednisone-equivalent at least 2 weeks prior to Day 1. b) If taking antimalarial: - No dose increase within 8 weeks prior to the Screening visit. - After the Screening visit (i.e., during the Screening Period and the Treatment Period), dosing must be stable and as follows: hydroxychloroquine ≤ 400 mg/day, quinacrine ≤ 100 mg/day, or chloroquine ≤ 250 mg/day. c) If taking immunosuppressant: - No dose increase within 8 weeks prior to the Screening visit. - After the Screening visit (i.e., during the Screening period and the Treatment period), must be taking no more than 1 immunosuppressant and at a stable dose as follows: mycophenolate mofetil ≤ 3 g/day, mycophenolate sodium ≤ 2160 mg/day, azathioprine ≤ 200 mg/day, 6- mercaptopurine ≤ 100 mg/day, methotrexate ≤ 25 mg/week, cyclosporine ≤ 2 mg/kg/day, tacrolimus ≤ 3 mg/day, or voclosporin ≤ 23.7 mg twice daily.

You likely can't join if

Patients are excluded from the study if any of the following criteria apply: 1. Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient’s safety or additional therapy that is not permitted in the protocol is needed.
10. Malignancy within 5 years except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin.
11. History of drug or alcohol abuse in the previous 12 months before screening in the opinion of the investigator.
12. Use prior to screening of one or more of the following: a) Within 6 months: rituximab or similar major B cell-depleting biologic therapy, or T cell-depleting agent such as Campath (alemtuzumab). Note: Patients who received B-cell-targeted therapy > 6 and ≤ 12 months prior to randomization must have a B-cell count that is within the laboratory reference range at screening, as measured by the central laboratory. b) Within 1 month: belimumab or any inhibitor of B cell activating factor (BAFF) and/or APRIL, anifrolumab, abatacept, infliximab, adalimumab, certolizumab, golimumab, etanercept, tocilizumab, anakinra, immunoglobulin, blood products, cyclophosphamide IV or oral, live or live-attenuated vaccine, or other biologics with immunomodulating/immunosuppressive activity. c) Within 5 half-lives or 30 days, whichever is longer: any investigational drug.
13. Use after the Screening visit of medical treatment (including prescription drugs, non-prescription drugs, biological products, Chinese or herbal medicines, diet supplements, etc.) or health care products considered by the investigator or central adjudicator to potentially impact the interpretation of study results.
14. Currently enrolled in another interventional clinical study. Note: Patients enrolled in ongoing cohort or non-interventional studies may not donate blood or tissue samples for such studies during their participation in this study (including the Follow-up Period). All the other exclusion criteria can be found in the protocol (section 5.2.2).

See the full eligibility criteria

Who can join

1. ≥ 18 to ≤ 70 years of age.
2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.
3. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.
4. At screening, at least one of the following: a) anti-nuclear antibody (ANA) ≥ 1:80 b) positive anti-dsDNA c) positive anti-Sm
5. Patient has all 3 of the following based on features active on the day of the visits: a) hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1. Note: Clinical points exclude laboratory tests, except proteinuria. Patients with proteinuria scored as present (i.e., urine protein/creatinine > 500 mg/g) at screening will also be scored as present on Day 1 if a dipstick performed at the site on Day 1 is at least 2+ proteinuria. If the urine protein/creatinine > 500 mg/g at screening is not known to be stable based on recent past proteinuria testing, then a repeat urine protein/creatinine measurement is required during the Screening Period. b) BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1. c) In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.
6. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant. The treatment regimen must be as below: a) If taking oral corticosteroid: No increase in dosing regimen during the Screening Period, and at stable dose ≤ 20 mg/day prednisone-equivalent at least 2 weeks prior to Day 1. b) If taking antimalarial: - No dose increase within 8 weeks prior to the Screening visit. - After the Screening visit (i.e., during the Screening Period and the Treatment Period), dosing must be stable and as follows: hydroxychloroquine ≤ 400 mg/day, quinacrine ≤ 100 mg/day, or chloroquine ≤ 250 mg/day. c) If taking immunosuppressant: - No dose increase within 8 weeks prior to the Screening visit. - After the Screening visit (i.e., during the Screening period and the Treatment period), must be taking no more than 1 immunosuppressant and at a stable dose as follows: mycophenolate mofetil ≤ 3 g/day, mycophenolate sodium ≤ 2160 mg/day, azathioprine ≤ 200 mg/day, 6- mercaptopurine ≤ 100 mg/day, methotrexate ≤ 25 mg/week, cyclosporine ≤ 2 mg/kg/day, tacrolimus ≤ 3 mg/day, or voclosporin ≤ 23.7 mg twice daily.
7. Female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5. OR b) A WOCBP who meets all of the following: - Agrees to either sexual abstinence or use of contraception (as detailed in Appendix 5) until at least 8 weeks after the last administration of IMP. - Has a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to the first dose of IMP. - Agrees to refrain from egg donation until at least 8 weeks after the last dose of IMP.
8. A male patient is eligible if the following conditions apply: - Agrees to either sexual abstinence or use of contraception (as detailed in Appendix 5) until at least 8 weeks after the last dose of IMP or is surgically sterile. AND Agrees to refrain from donating sperm until at least 8 weeks after the last dose of IMP.

What rules you out

Patients are excluded from the study if any of the following criteria apply: 1. Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient’s safety or additional therapy that is not permitted in the protocol is needed.
10. Malignancy within 5 years except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin.
11. History of drug or alcohol abuse in the previous 12 months before screening in the opinion of the investigator.
12. Use prior to screening of one or more of the following: a) Within 6 months: rituximab or similar major B cell-depleting biologic therapy, or T cell-depleting agent such as Campath (alemtuzumab). Note: Patients who received B-cell-targeted therapy > 6 and ≤ 12 months prior to randomization must have a B-cell count that is within the laboratory reference range at screening, as measured by the central laboratory. b) Within 1 month: belimumab or any inhibitor of B cell activating factor (BAFF) and/or APRIL, anifrolumab, abatacept, infliximab, adalimumab, certolizumab, golimumab, etanercept, tocilizumab, anakinra, immunoglobulin, blood products, cyclophosphamide IV or oral, live or live-attenuated vaccine, or other biologics with immunomodulating/immunosuppressive activity. c) Within 5 half-lives or 30 days, whichever is longer: any investigational drug.
13. Use after the Screening visit of medical treatment (including prescription drugs, non-prescription drugs, biological products, Chinese or herbal medicines, diet supplements, etc.) or health care products considered by the investigator or central adjudicator to potentially impact the interpretation of study results.
14. Currently enrolled in another interventional clinical study. Note: Patients enrolled in ongoing cohort or non-interventional studies may not donate blood or tissue samples for such studies during their participation in this study (including the Follow-up Period). All the other exclusion criteria can be found in the protocol (section 5.2.2).
2. A history of thrombosis or embolism in the previous 6 months before the Screening visit, or thrombotic history in the previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state. A thrombotic history associated with APS or another relevant hypercoagulable state more than 12 months prior to Screening visit is excluded if it is not treated per local standards with prophylactic anticoagulation.
3. Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE, such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.
4. Active severe neuropsychiatric or CNS SLE.
5. Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator. Current diagnosis of thyroiditis or secondary Sjogren's Syndrome is permitted.
6. Presence of uncontrolled or New York Heart Association Class III or IV congestive heart failure.
7. Any condition or finding on physical exam, current or previous medical history, vital signs, 12-lead ECG, or laboratory tests that, in the opinion of the investigator or central adjudicator, might interfere with the evaluation of the investigational product or should otherwise exclude a patient.
8. Surgery (not considered minor by the investigator or the central adjudicator) within 4 weeks before Screening, or planned surgery during the study.
9. History of relevant allergies, including allergy to study drug or any murine or human-derived protein or immunoglobulin products that, in the opinion of the investigator or central adjudicator, make inclusion in the study inappropriate.

The study team makes the final eligibility decision.

Where it's taking place

Mexico
South Africa
China
Canada
United States
Japan
Taiwan

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Mexico; South Africa; China; Canada; United States; Japan 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.