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Using RPH-104 to prevent fever attacks in patients with Familial Mediterranean Fever who can't tolerate colchicine

An International Multicenter Open-label Clinical Study of the Safety and Efficacy of RPH-104 for Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine

Phase 2 Interventional R-Pharm · NCT05190991

This study is testing if RPH-104 can help adults with Familial Mediterranean Fever who can’t take colchicine by preventing their fever attacks over a long period.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorR-Pharm Industry-sponsored
Drugs / interventionstocilizumab, rituximab, canakinumab, tofacitinib, baricitinib, methotrexate, cyclophosphamide
Locations8 sites (Yerevan and 7 other locations)
Trial IDNCT05190991 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of RPH-104, administered subcutaneously every two weeks, in adult patients with Familial Mediterranean Fever (FMF) who are resistant to or intolerant of colchicine. It is an open-label extension of a previous core study, allowing participants who completed that study to continue receiving treatment. The study will last for 198 weeks, during which patients will receive either 80 mg or 160 mg doses of RPH-104 based on their previous treatment response. The aim is to determine the long-term effectiveness of RPH-104 in preventing recurrent fever attacks.

Who should consider this trial

Good fit: Ideal candidates are adults with Familial Mediterranean Fever who have previously participated in a core study and have shown resistance to or intolerance of colchicine.

Not a fit: Patients who do not have Familial Mediterranean Fever or those who have not previously participated in the core study will not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of fever attacks in patients with colchicine-resistant or intolerant FMF.

How similar studies have performed: While this approach is based on previous studies, the specific use of RPH-104 in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The patient with Familial Mediterranean Fever (FMF) with resistance to or intolerance of colchicine, who completed the core study, during which he/she received at least one dose of RPH-104.
2. Voluntarily signed and dated Patient Informed Consent Form (ICF) for participation in this study.
3. The patient's ability and desire, according to the Investigator's discretion, to follow the schedule of visits, follow the study procedures and follow the Protocol requirements, including the following:

   * to visit the study site every 2 weeks for RPH-104 administration by qualified study site personnel

or

• to learn the subcutaneous (SC) injection technique and self-administer RPH-104 at his/her accommodation as per the study Protocol

or

• to agree with the qualified medical personnel visits to his/her accommodation for RPH-104 administration.

Exclusion Criteria:

1. Any medically significant event that was observed in a patient during his/her participation in the core study, as well as any other medical conditions (including psychiatric disorders) or laboratory abnormalities, which may increase the potential risk associated with participation in the study and treatment with RPH-104, or may affect the interpretation of the study results, and which, according to the Investigator's opinion, may lead to the patient's non-compliance with the study inclusion criteria.
2. Pregnant and/or lactating women or women planning pregnancy during the study or within 2 months after the last RPH-104 dose.
3. Women of childbearing potential, i.e. all females with physiological ability to conceive except for those with final cessation of menses, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status, for example, at respective age, who do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose or Men who are sexually active and do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose.

   Highly effective contraception methods include:
   * complete abstinence: if it corresponds to the preferred and conventional lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation method) and interrupted coitus are not considered acceptable contraceptive methods;
   * female sterilization: surgical bilateral ovariectomy (with/without hysterectomy) or tubal ligation at least 6 weeks before the start of the core study. In a case of ovariectomy only, the female reproductive status should be verified by further hormonal test;
   * male sterilization (with documented absence of sperm in ejaculate post vasectomy) at least 6 months before the start of the core study. Vasectomized male partner should be the only partner of the participating female subject;
   * combination of any two of the following methods (a+b or a+c or b+c):

     1. use of oral, injectable or implanted hormonal contraceptives; in a case of oral contraceptives, the woman should constantly use the same product as was used during the core study;
     2. installation of an intrauterine device or contraceptive system;
     3. use of barrier contraceptives: condom or occlusive cap (diaphragm or cervical cap/contraceptive vaginal ring) with spermicidal foam/gel/film/cream/vaginal suppository
4. The need for a therapy with any of the following products from the moment of signing the ICF till the study treatment period completion:

   * systemic glucocorticoids at a dose exceeding 0,2 mg/kg/day of prednisolone (or 0,16 mg/kg/day of methylprednisolone, or an equivalent dose of another glucocorticoid) orally;
   * rilonacept, tocilizumab, rituximab, canakinumab, tumor necrosis factor alpha (TNF-a) inhibitors (TNFi) and other biological products (except for RPH-104);
   * immunosuppressants (cyclosporine, methotrexate, leflunomide, thalidomide, azathioprine, 6-mercaptopurine, cyclophosphamide, etc.);
   * methylprednisolone (or an equivalent) at a dose of more than 40 mg/day parenterally;
   * intramuscular, intra-articular or peri-articular administration of glucocorticoids;
   * anakinra;
   * tofacitinib, baricitinib;
   * any experimental drugs (except for RPH-104)
5. The need to use a live (attenuated) vaccine during the study or within 3 months after the last RPH-104 dose. Live attenuated vaccines include vaccines against viruses: measles, rubella, mumps, chickenpox, rotavirus, flu (as a nasal spray), yellow fever, polio (oral polio vaccine); vaccines against tuberculosis (BCG), typhoid fever (oral typhoid vaccine) and typhus (typhus vaccine). Immunocompetent family members of the patient should not be vaccinated with the oral polio vaccine during the patient's participation in the study
6. Positive results of tuberculosis screening performed at Visit 10 of the core study (QuantiFERON-Tuberculosis(TB)/T-Spot.TB test, chest X-ray).
7. Participation in other experimental studies (except for the core study).

Where this trial is running

Yerevan and 7 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Familial Mediterranean FeverFMFRPH-104colchicine inefficacycolchicine intolerancecolchicine resistancesubcutaneousinterleukin-1 inhibitor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.