Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis

NCT04692766 | Completed Phase 2

• 1 other identifier: CL04018068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study was to evaluate the Efficacy and Safety of RPH-104 Treatment in patients in comparison to placebo with Idiopathic Recurrent Pericarditis

Conditions

Pericarditis

Outcome Measures

Primary Outcomes (1)

• Time (days) to the recurrence within 24 weeks after randomization

  Time (days) to the recurrence within 24 weeks after randomization in patients with idiopathic recurrent pericarditis treated with RPH-104 compared to placebo.

  up to 24 weeks after randomization

Secondary Outcomes (17)

• Proportion of patients demonstrating a response to RPH-104 treatment

  Day 3, Day 7, Day 14 of the run-in treatment period

• The proportion of patients switched to active treatment with RPH-104

  Day 3, Day 7, Day 14 of the run-in treatment period

• Proportion of patients with pericarditis recurrence throughout the run-in treatment period

  up to 24 weeks

• Proportion of patients, treated with RPH-104 with pericarditis recurrence recurrence within 24 weeks after the randomization, compared to placebo.

  up to 24 weeks

• Proportion of patients who completely discontinued corticosteroids within 12 weeks following the response to therapy throughout the run-in treatment period.

  up to 24 weeks

Study Arms (2)

RPH-104 80 mg

EXPERIMENTAL

subjects will receive RPH-104 at a dose of 80 mg subcutaneously once every 2 weeks

Biological: RPH-104

Placebo

PLACEBO COMPARATOR

subjects will receive placebo subcutaneously once every 2 weeks

Drug: Placebo

Interventions

RPH-104 BIOLOGICAL

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

RPH-104 80 mg

Placebo DRUG

Normal Saline (0.9% Sodium Chloride solution for Injection), 5 mL in a polypropylene ampoule, 10 ampoules per labeled package

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed and dated Informed Consent Form for participation in the study.
• Confirmed diagnosis of idiopathic recurrent pericarditis, established on the basis of the European Society of Cardiology (ESC) diagnostic criteria (2015):
• The patients may be enrolled in the study with signs of disease recurrence or without them (while on therapy with NSAIDs/GCS/colchicine: any of these drugs or their combinations), but they have to have at least two documented episodes of pericarditis at least 4-6 weeks in between (the second episode can be verified at the moment of the study site visit).
• For patients with signs of relapse, stable therapy (i.e., unchanged dosages and regimen) with NSAIDs/GCSs for not less than 3 days and/or with colchicine for not less than 7 days before screening.
• For patients without signs of relapse: continuous therapy with NSAIDs/GCS/colchicine (any of the drugs or their combination).
• The patient's ability and willingness (in the reasonable opinion of the Investigator) to come to the study site for all scheduled visits, to undergo all study procedures and comply with the protocol requirements, including consent to subcutaneous injections by qualified personnel of the study site.
• Consent of women of childbearing potential (defined as all women with a physiological ability to become pregnant) to use highly effective contraceptive methods throughout the study, starting from the beginning of the screening (signing of the Informed Consent Form) and for at least 8 weeks after discontinuation of the study drug; and the negative pregnancy test result (serum test for chorionic gonadotropin).
• OR Consent of sexually active male subjects to use highly effective contraceptive methods throughout the study, starting from the beginning of the screening and for at least 8 weeks after discontinuation of the study drug.
• Highly effective methods of contraception include the following:
• Complete abstinence (if it agrees with the preferable and usual lifestyle of the patient). Periodic abstinence (for example, calendar, ovulation, symptothermal, postovulation methods) and interrupted sexual intercourse are not considered acceptable methods of contraception;
• Sterilization: surgical bilateral oophorectomy (with or without uterectomy) or ligation of the fallopian tubes at least 6 weeks before the start of the study therapy. If only oophorectomy was performed, the woman's reproductive status should be confirmed by a subsequent assessment of the hormone test;
• Sterilization of a male partner at least 6 weeks before the start of the study therapy (with proper documented absence of sperm in the ejaculate after vasectomy). In women participating in the study, the sexual partner after vasectomy should be the only partner;
• use of a combination of any two of the following (a+b or a+c or b+c):
• the use of oral, injectable or implanted hormonal contraceptives; in the case of oral contraceptives, women should consistently use the same drug for a minimum of 3 months prior to the initiation of the study treatment;
• placement of an intrauterine device (IUD) or intrauterine system (IUS);

You may not qualify if:

• Hypersensitivity to the study drug (RPH-104), and/or its components/excipients and/or drugs of the same chemical class.
• History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
• Diagnosis of pericarditis of known etiology (tuberculosis-related, tumor-induced, bacterial), rheumatic diseases.
• Other previously diagnosed auto-inflammatory diseases.
• Prior therapy with:
• rilonacept - less than 6 weeks prior to the baseline assessment (Day 0 of the run-in treatment period);
• canakinumab - less than 12 weeks prior to the baseline assessment (Day 0 of the run-in treatment period);
• anakinra - less than 5 weeks prior to the baseline assessment (Day 0 of the run-in treatment period);
• Tumor necrosis factor (TNF) inhibitors, Interleukin 6 (IL-6) inhibitors, Janus kinase inhibitors - less than 12 weeks prior to the baseline assessment (Day 0 of the run-in treatment period);
• immunosuppressive agents (azathioprine, cyclosporine, mycophenolate, mofetil, tacrolimus, sirolimus, mercaptopurine) - less than 24 weeks prior to the baseline assessment (Day 0), methotrexate - less than two weeks prior to the baseline assessment (Day 0),
• any other biological preparations less than 5 half-lives prior to the treatment initiation (Day 0 of the preparatory therapy period).
• The use of live (attenuated) vaccine within 3 months prior to Day 0 (of the run-in treatment period and/or the need to use this type of a vaccine within 3 months after the discontinuation of the study drug. Live attenuated vaccines include vaccines against viral infections such as measles, rubella, mumps, chickenpox, rotavirus, influenza (in the form of a nasal spray), yellow fever, polio (oral polio vaccine); vaccines against tuberculosis (BCG), typhoid (oral typhoid vaccine) and typhus (epidemic typhoid vaccine) vaccines. Patient's immunocompetent family members should refrain from administration of a polio vaccine during the patient's participation in the study.
• Any conditions or signs in the patient that, according to the investigator's judgement, indicate a disorder (suppression) of the patient's immune response and/or significantly increase the risk of immunomodulatory therapy, including, but not limited to, the following:
• active bacterial, fungal, viral or protozoal infection revealed at the beginning of the screening period;
• opportunistic infections and/or Kaposi's sarcoma at the beginning of the screening period;

Sponsors & Collaborators

• R-Pharm International, LLC: lead
• Unimed Laboratories: collaborator
• Data Management 365: collaborator
• Center of Pharmaceutical Analytics LLC: collaborator

Study Sites (2)

Federal Budgetary Healthcare Institution Orenburg Regional Clinical Hospital

Orenburg, 460018, Russia

Location

Federal State Budget Institution "V.A. Almazov National Medical Research Center" of Ministry of Healthcare of Russian Federation

Saint Petersburg, 197341, Russia

Location

Related Publications (1)

• Myachikova VY, Maslyanskiy AL, Moiseeva OM, Vinogradova OV, Gleykina EV, Lavrovsky Y, Abbate A, Grishin SA, Egorova AN, Schedrova ML, Samsonov MY. Treatment of Idiopathic Recurrent Pericarditis With Goflikicept: Phase II/III Study Results. J Am Coll Cardiol. 2023 Jul 4;82(1):30-40. doi: 10.1016/j.jacc.2023.04.046.

  PMID: 37380301 DERIVED

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: February 12, 2020
• Primary Completion: January 24, 2022
• Study Completion: March 22, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)