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RPH-104 for Schnitzler Syndrome
Phase 2
Waitlist Available
Research Sponsored by R-Pharm Overseas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening
Summary
This trial is testing a new drug to treat Schnitzler Syndrome, a rare disease. They will measure how well the drug works by looking at the disease activity score, which includes the doctor's assessment and a laboratory test.
Who is the study for?
Adults with Schnitzler Syndrome who agree to use effective contraception can join this trial. They must have a confirmed diagnosis, including chronic hives and specific blood markers like IgM or IgG, plus two other symptoms such as fever or bone pain. Participants should be willing to follow the study plan and attend all visits.
What is being tested?
The trial is testing RPH-104's effectiveness and safety in treating Schnitzler Syndrome by comparing it with a placebo. The main measure is the Schnitzler Disease Activity Score which includes doctors' assessments and CRP levels from local labs.
What are the potential side effects?
While not explicitly listed, potential side effects of RPH-104 may include reactions at the injection site, allergic responses due to hypersensitivity to components of the drug, or general medication-related side effects such as fatigue or digestive issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of subjects with complete response (Schnitzler Disease Activity Score (SDAS = 0)) to therapy on Day 14 in the RPH-104 group as compared to the placebo group
Secondary study objectives
Change from baseline to Day 14 and Day 28 in CRP and SAA
Change from baseline to Day 14 in subject-reported symptom severity of SchS: Patient-reported Severity of Schnitzler Syndrome Scale (PR-SchS Scale)
Proportion of subjects with complete response (SDAS = 0) to therapy on Day 28 by treatment sequence based on SDAS using the Physician's Global Assessment (PGA) and the CRP result
+2 moreOther study objectives
Change from baseline to Day 14 and Day 28 in Binding and neutralizing antidrug antibodies levels
Change from baseline to Day 14 and Day 28 in IL-1β, IL-1α, IL-1RA, and IL-6 levels
Change from baseline to Day 14 and Day 28 in IgA levels
+17 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo - 80 mg RPH-104Experimental Treatment2 Interventions
Subject randomized to receive subcutaneous single injection of placebo on Day 0,and then, on Day 14 - second dose of randomized treatment + based on the lack of response (no change in SDAS) or partial response to treatment (SDAS ≥ 1, and activity reduction by 1 or more points of SDAS compared to baseline) subcutaneous single injection of 80 mg RPH-104
Group II: 80 mg RPH-104 - 80 mg RPH-104Experimental Treatment2 Interventions
Subject randomized to receive subcutaneous single injection of 80 mg RPH-104 on Day 0,and then, on Day 14 - second dose of randomized treatment + based on the positive response to the treatment (SDAS = 0) one subcutaneous injection of placebo
Group III: 80 mg RPH-104 - 160 mg RPH-104Experimental Treatment1 Intervention
Subject randomized to receive subcutaneous single injection of 80 mg RPH-104 on Day 0,and then, on Day 14 - second dose of randomized treatment + based on the lack of response (no change in SDAS) or partial response to treatment (SDAS ≥ 1, and activity reduction by 1 or more points of SDAS compared to baseline) one more subcutaneous injection of 80 mg RPH-104
Group IV: Placebo - placeboPlacebo Group1 Intervention
Subject randomized to receive subcutaneous single injection of placebo on Day 0,and then, on Day 14 - second dose of randomized treatment + based on the positive response to treatment (SDAS = 0) one more dose of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Worldwide Clinical TrialsOTHER
64 Previous Clinical Trials
14,775 Total Patients Enrolled
R-Pharm Overseas, Inc.Lead Sponsor
2 Previous Clinical Trials
182 Total Patients Enrolled
Yan LavrovskyStudy DirectorR-Pharm Overseas, Inc.
2 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a live vaccine within the last 3 months or need to receive one within 3 months after Day 70.You are currently taking high doses of steroid pills or have received steroid injections near your joints within the last 4 weeks.You have a type of disease that affects your lymph nodes.You are allergic to the study drug RPH 104 or any of its ingredients.You have other health conditions that could affect your ability to take part in the study or could make it hard to see how well the treatment is working.You are currently taking certain medications that weaken your immune system.You have opportunistic infections or Kaposi's sarcoma at the time of screening.Your kidneys are not working well, with a specific measure of kidney function less than 30 mL/min.You have been diagnosed with Schnitzler syndrome based on specific criteria, including a chronic skin rash, certain levels of immunoglobulins in your blood, and at least two of the following: fever, joint pain, bone pain, swollen lymph nodes, enlarged liver or spleen, high levels of ESR or white blood cells, and bone abnormalities.You are currently taking other biologic medications, or have taken them within the last 4 weeks or 5 times their half-life before the start of the study.You had cancer, except for certain types of skin cancer, within the past 5 years.Your blood tests show low white blood cell or platelet counts, or high levels of certain liver enzymes.You have had a bacterial, fungal, or viral infection in the past 4 weeks.You have had a long-lasting bacterial, fungal, or viral infection that needed strong antibiotics or antiviral medication within the last 4 weeks.You are currently taking anakinra (Kineret) or have taken it within the last 5 days.You have a history of tuberculosis, or you currently have tuberculosis infection as confirmed by medical tests.You have symptoms of SchS and high levels of CRP in your blood on the day of the study.
Research Study Groups:
This trial has the following groups:- Group 1: 80 mg RPH-104 - 160 mg RPH-104
- Group 2: Placebo - 80 mg RPH-104
- Group 3: 80 mg RPH-104 - 80 mg RPH-104
- Group 4: Placebo - placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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