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Tests treatment safety and results for Relapsed/Refractory Rheumatic and Immunologic...
Official title A Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])
ClinicalTrials.gov ID: NCT07208058
What this study is testing
What is Plonmarlimab?
Plonmarlimab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for relapsed/refractory rheumatic and immunologic disease-associated haemophagocytic lymphohistiocytosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study designed to evaluate the efficacy, safety, immunogenicity, PK, and PD characteristics of Plonmarlimab in patients with relapsed/refractory rheumatic and immunologic disease-associated MAS, and to explore biomarkers related to the efficacy of Plonmarlimab.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 80
You may be able to join if
- Age: 16 to 80 years (inclusive), of any gender.
- The subject is willing to participate in this study and voluntarily signs the informed consent form. For minor people aged 16 years (inclusive) to...
- Diagnosed with a rheumatic and immunological disease.
- Diagnosed with haemophagocytic lymphohistiocytosis (HLH) according to the HLH-2004 diagnostic criteria (excluding molecular diagnosis)
- No response to/or dependence on/intolerance to/or worsening during high-dose corticosteroid therapy. High-dose corticosteroid therapy: at least...
You likely can't join if
- Confirmed or suspected primary haemophagocytic lymphohistiocytosis (pHLH).
- HLH induced by infection (including but not limited to EBV-HLH) or treatment (including but not limited to drugs such as CAR-T cells, TCEs, ADCs).
- History of other active neoplasm malignant within 5 years prior to screening, with the exception of successfully treated cutaneous basal cell or...
- History of allergy to any component of the investigational drug.
- Lung disorder: including but not limited to asthma, chronic obstructive pulmonary disease, interstitial lung disease, alveolar proteinosis, pulmonary...
- Cardiovascular disorder: history of acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multifocal frequent premature...
See the full eligibility criteria
- Age: 16 to 80 years (inclusive), of any gender.
- The subject is willing to participate in this study and voluntarily signs the informed consent form. For minor people aged 16 years (inclusive) to less than 18 years, written informed consent must be signed by both the...
- Diagnosed with a rheumatic and immunological disease.
- Diagnosed with haemophagocytic lymphohistiocytosis (HLH) according to the HLH-2004 diagnostic criteria (excluding molecular diagnosis)
- No response to/or dependence on/intolerance to/or worsening during high-dose corticosteroid therapy. High-dose corticosteroid therapy: at least 1.5-2.0 mg/kg/d of prednisone or its equivalent dose for 3 consecutive...
- Confirmed or suspected primary haemophagocytic lymphohistiocytosis (pHLH).
- HLH induced by infection (including but not limited to EBV-HLH) or treatment (including but not limited to drugs such as CAR-T cells, TCEs, ADCs).
- History of other active neoplasm malignant within 5 years prior to screening, with the exception of successfully treated cutaneous basal cell or squamous cell carcinoma, or localised neoplasms that have been adequately...
- History of allergy to any component of the investigational drug.
- Lung disorder: including but not limited to asthma, chronic obstructive pulmonary disease, interstitial lung disease, alveolar proteinosis, pulmonary granulomatosis, etc., and abnormal pulmonary function tests: forced...
- Cardiovascular disorder: history of acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multifocal frequent premature ventricular contractions, ventricular tachycardia, ventricular fibrillation)...
- Infection: Presence of an infection deemed uncontrollable by the investigator during the screening period [including but not limited to tuberculosis, active syphilis infection, viral infection (EBV, CMV, COVID-19...
- Abnormal renal function: creatinine (Cr) or urea/blood urea nitrogen (BUN) test value \>1.5 times the upper limit of normal (ULN); or eGFR \<60 mL/min during the screening period, calculated using the MDRD formula: eGFR...
- Haematological diseases: people with a past or current history of haematological diseases (including but not limited to, myelofibrosis, aplastic anaemia, leukaemia, lymphoma, etc.).
- Surgery or other conditions: Planned surgery or any other medical history, laboratory test abnormal, or other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
- Transplant: History of major organ transplant (e.g., heart, lung, kidney, liver) or haematopoietic stem cell/bone marrow transplant.
- Other diseases: Subject currently has a clinically significant and clinically unstable or inadequately controlled acute or chronic disease (e.g., acute pneumonia, pulmonary arterial hypertension, diabetic ketoacidosis...
- Pregnant or lactating women.
- Participation in any clinical trial (including investigational vaccines) treatment or use of an invasive investigational medical device within 3 months prior to enrolment, or currently enrolled in an treatment study.
- Received live vaccine within 30 days prior to screening.
- Evidence of alcohol abuse within 3 months prior to screening or current abuse, identified through medical history inquiry.
- Other conditions that, in the investigator's opinion, make the subject unsuitable for participation in this clinical study. For example, any condition that may increase the risks associated with the subject's...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
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, 16 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Shijiazhuang, Hebei, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.