MedTrace Logo

Efficacy and Safety Clinical Study of RPH-104 in Adult Onset Still's Disease (AOSD)

NCT05432960 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-11-15

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the efficacy of RPH-104 when administered at a dose of 160 mg on Day 0, Day 7, Day 21 and then once every 2 weeks (Q2W) subcutaneous (SC) in patients with Adult Onset Still's Disease (AOSD). Furthermore, the study is scheduled to investigate pharmacokinetic (PK) and pharmacodynamic (PD) parameters of RPH-104.

Conditions

  • Adult-Onset Still's Disease
  • AOSD

Interventions

BIOLOGICAL

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)

Sponsors & Collaborators

  • Exacte Labs LLC

    collaborator INDUSTRY

  • Ministry of Health, Russian Federation

    collaborator OTHER_GOV

  • Scientific Center EFiS LLC

    collaborator UNKNOWN

  • Data Management 365

    collaborator INDUSTRY

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · Chief Medical Officer, R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Russia

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 NCT05432960 on ClinicalTrials.gov