← Back to Search

Other

Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine

Phase 2

Waitlist Available

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

Summary

Study purpose is an evaluation of efficacy and safety of RPH-104 in the population of subjects with Familial Mediterranean Fever (FMF) with colchicine resistance or intolerance(i.e. colchicine resistant (crFMF).. Primary objective is to determine proportion of subjects with complete response to treatment with RPH-104 compared to placebo among FMF subjects with colchicine resistance or intolerance.

Eligible Conditions

Familial Mediterranean Fever

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 7 to the development of a recurrent fmf attack, up to 16 weeks

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

Musculoskeletal and connective tissue disorders

Pollakiuria

Skin and subcutaneous tissue disorders

Investigations

Respiratory, thoracic and mediastinal disorders

Psychiatric disorders

Ear and labyrinth disorders

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location