Efficacy and Safety Clinical Study of RPH-104 in Adult Onset Still's Disease (AOSD) (NCT05432960) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety Clinical Study of RPH-104 in Adult Onset Still's Disease (AOSD)
Stopped: Study halted according to the Sponsor's descision.
Russia0Started 2023-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Presence of voluntarily signed and dated Informed Consent Form to participate in this study.
. Definite diagnosis of Still's disease made on the basis of Yamaguchi diagnostic criteria (Yamaguchi M., 1992).
. A patient with AOSD (with inactive disease / low disease activity / exacerbation).
. In case of current GCs administration, their doses should be stable for at least 2 weeks prior to Day 0. Maximum acceptable dose calculated as 1 mg/kg/day is up to 60 mg/day.
. In case of on-going methotrexate (MTX) administration, the dose should be stable for at least 4 weeks prior to Day 0. Maximum acceptable dose is 30 mg/week. In case of withdrawal of previous MTX administration, it should be made at least 4 weeks before Day 0.
. Ability and willingness of the subject, according to the reasonable investigator's judgment, to attend the study site at all scheduled visits, undergo the study procedures and follow the protocol requirements including subcutaneous injections by qualified site personnel.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time (number of days) to exacerbation during 24 weeks after randomization while taking RPH-104 vs placebo in patients with AOSD
Timeframe: from randomization (visit 16, week 29) to exacerbation, up to week 53
. Consent of female subjects with childbearing potential, defined as all females with physiological potential to conceive (except for those with absolute termination of menses to be determined retrospectively after 12 months of natural amenorrhea, i. e. amenorrhea with relevant clinical status, e. g. appropriate age) to use highly effective contraception throughout the study starting from the screening (signed Informed Consent Form) and for at least 8 weeks after discontinuation of the study product administration; and negative pregnancy test (serum test for chorionic gonadotropin).
. oral, injection or implanted hormonal contraceptives; in case of oral contraceptives, the female subjects should administer the same product for at least 3 months prior to the study therapy;
Exclusion criteria
. Hypersensitivity to the investigational product (RPH-104) and/or its ingredients/excipients.
. Previous administration of:
. Administration of live (attenuated) vaccine less than 3 months prior to Visit 1 (study treatment period initiation) and/or necessity to use such vaccine within 3 months after the study therapy discontinuation. Live attenuated vaccines include viral vaccines against: measles, rubella, parotitis, varicella, rotavirus, influenza (as nasal spray), yellow fever, poliomyelitis (oral polio-vaccine), tuberculosis vaccine (BCG), typhoid (oral typhoid fever vaccine) and camp fever (epidemic typhoid vaccine). Immunocompetent family members should refuse to use oral polio-vaccine throughout the subject's participation in the study.
. Conditions or signs which, according to the investigator, suggest impaired (reduced) immune response and/or significantly increase the risk of immunomodulating therapy including (but not limited to):
. Active infection of M. Tuberculosis, as per examination results: positive QuantiFERON-TB/SPOT.TB test at screening, chest X-ray findings confirming pulmonary tuberculosis during screening.
. Any other relevant concomitant diseases (cardiovascular, nervous, endocrine, urinary, gastrointestinal, hepatic disorders, hemostatic disorders, other autoimmune diseases, etc.) or conditions which, according to the investigator's judgment, may affect the subject's participation or well-being in the study and/or distort assessment of the study results.
. History of organ transplantation or necessity in transplantation at the screening onset.
. Any malignancies during the screening period or for 5 years before screening except for non-metastatic basal cell and squamous cell skin cancer after total resection or in situ carcinoma of any type after total resection.