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RPH-104 for Familial Mediterranean Fever

Phase 2
Recruiting
Research Sponsored by R-Pharm International, LLC
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 from day 7 to the development of a recurrent fmf attack, up to 16 weeks
Awards & highlights

Summary

The primary purpose of this study is to assess the efficacy and safety profiles of investigational product RPH-104 (R-Pharm Overseas, Inc., USA) for treatment of Familial Mediterranean Fever (FMF) in adult patients resistant/intolerant to colchicine (crFMF). Pharmacokinetic and pharmacodynamic parameters of RPH-104 single or multiple doses in this patient population will be assessed as well.

Eligible Conditions
  • Familial Mediterranean Fever

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 7 to the development of a recurrent fmf attack, up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 7 to the development of a recurrent fmf attack, up to 16 weeks for reporting.

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 during 16 week therapy with RPH-104 vs. placebo in FMF subjects with colchicine inefficacy or intolerance.
Secondary study objectives
Change in inflammation parameters vs. baseline (CRP)
Change in inflammation parameters vs. baseline (SAA)
Changes in patients' quality of life during the treatment period with RPH-104
+8 more

Side effects data

From 2017 Phase 1 trial • 35 Patients • NCT02667639
52%
Nervous system disorders
32%
Gastrointestinal disorders
24%
Infections and infestations
12%
General disorders and administration site conditions
8%
Musculoskeletal and connective tissue disorders
8%
Pollakiuria
8%
Skin and subcutaneous tissue disorders
8%
Investigations
4%
Respiratory, thoracic and mediastinal disorders
4%
Psychiatric disorders
4%
Ear and labyrinth disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RPH-104Experimental Treatment1 Intervention
Test product group receiving RPH-104 subcutaneous (s.c.) injections:160 mg on Day 0, 80 mg on Day 7, Day 14 and every 2 weeks (q2w) thereafter. In case "marker" attack does not resolve at Visit 2 - the treatment group will be unblinded: patients will receive planned RPH-104 80 mg administration. In case of a new attack on further days of treatment period until Visit 10 inclusive - the treatment group will be unblinded: the dose of RPH-104 could be escalated to 160 mg q2w; The patients already receiving RPH-104 160 mg q2w will continue to receive RPH-104 at this dose. Further dose escalation is forbidden.
Group II: PlaceboPlacebo Group1 Intervention
Placebo group receiving the equivalent placebo dose also as s.c. injections on Day 0, Day 7, Day 14 and q2w thereafter. In case the "marker" attack does not resolve at Visit 2 - the treatment group will be unblinded: patients will be switched to active treatment with RPH-104 in SC injections at a dose of 160 mg followed by administration of 80 mg in 7 days at the Attack + 7 days Visit, and 80 mg at the next Visits. In a case of a new attack the patients switching from placebo and receiving RPH-104 at 80 mg dose could be escalated to RPH-104 160 mg q2w; Further dose escalation is forbidden.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goflikicept
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Data Management 365Industry Sponsor
11 Previous Clinical Trials
4,210 Total Patients Enrolled
1 Trials studying Familial Mediterranean Fever
60 Patients Enrolled for Familial Mediterranean Fever
R-Pharm International, LLCLead Sponsor
11 Previous Clinical Trials
5,152 Total Patients Enrolled
1 Trials studying Familial Mediterranean Fever
60 Patients Enrolled for Familial Mediterranean Fever
Atlant Clinical LLCUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Familial Mediterranean Fever
60 Patients Enrolled for Familial Mediterranean Fever
~14 spots leftby Sep 2025
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