← Back to Search

Unknown

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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~screening
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more
Other outcome measures
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 more

Trial 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
61 Previous Clinical Trials
14,373 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

Placebo (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04213274 — Phase 2
Schnitzler Syndrome Research Study Groups: 80 mg RPH-104 - 160 mg RPH-104, Placebo - 80 mg RPH-104, 80 mg RPH-104 - 80 mg RPH-104, Placebo - placebo
Schnitzler Syndrome Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04213274 — Phase 2
Placebo (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04213274 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile qualify me to participate in this research project?

"The necessary criteria for participating in this medical trial is to be diagnosed with schnitzler syndrome and between the ages of 18-100. This research project hopes to enlist 14 eligible participants."

Answered by AI

Does this research project include individuals aged 55 or older?

"In order to be eligible for enrollment in this study, potential participants must fall within the age bracket of 18-100 years old. An additional 388 trials are taking place for those below 18 and 1076 more studies recruiting patients over 65."

Answered by AI

Are there numerous locations in the US administering this clinical experiment?

"Four distinct medical centres are participating in this clinical trial: Mayo Clinic (Rochester), Oregon Health & Science University (Portland), Penn State Health Hersey Medical Center (Hershey) and other sites."

Answered by AI

Are there potential hazards associated with ingesting 80 mg RPH-104?

"According to our team at Power, the safety of 80 mg RPH-104 was given a score of 2 as this is only Phase 2 trial. This implies that while there has been some data collected on its security profile, no such studies have delved into its efficacy."

Answered by AI

Has there been any precedent for this particular experiment?

"Since 2021, 80 mg RPH-104 has been investigated in clinical trials. The initial study was facilitated by Data Management 365 and involved 60 participants; this trial granted the medication Phase 2 drug approval. Currently, 4 active investigations are taking place at 5 sites across 4 nations regarding the same medicament."

Answered by AI

Is there a history of 80 mg RPH-104 being utilized in medical studies?

"Currently, 4 clinical trials related to the drug 80 mg RPH-104 are underway, with 1 of them in its third phase. Most tests take place in Denver, Colorado; however, 15 different locations are conducting research on this pharmaceutical."

Answered by AI

Is participation in the experiment open to prospective participants?

"According to clinicaltrials.gov, the initial post for this medical study was published on May 1st 2023 and last updated on December 21st 2022. However, recruitment is not currently underway; but 1494 other trials are seeking participants at present."

Answered by AI

What is the aggregate number of individuals who are participating in this research?

"Unfortunately, this experiment has concluded its recruitment phase. Initially posted on the 1st of May 2023 and last updated on the 21st December 2022, it is no longer in search of candidates. However, there are 1490 trials for those with Schnitzler Syndrome and 4 studies associated with 80mg RPH-104 actively recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome
2023. "Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04213274.
~7 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top