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Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome

NCT04213274 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-11-15

No results posted yet for this study

Summary

The primary goal of the study is to assess the efficacy and safety of RPH-104 in subjects with Schnitzler Syndrome using Schnitzler Disease Activity Score (SDAS), which includes the Physician's Global Assessment (PGA) and the local laboratory C-reactive protein (CRP) result

Conditions

  • Schnitzler Syndrome
  • Urticarial Vasculitis With Monoclonal Immunoglobulin M Component, Schnitzler (Disorder)

Interventions

BIOLOGICAL

80 mg RPH-104

solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

DRUG

Placebo

Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4 mL-glass vial

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • R-Pharm Overseas, Inc.

    lead INDUSTRY

Principal Investigators

  • Yan Lavrovsky · R-Pharm Overseas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-08-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04213274 on ClinicalTrials.gov