Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05432960
Other study ID # CL04018093
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date December 2023
Est. completion date August 2025

Study information

Verified date September 2023
Source R-Pharm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Intervention

Biological:
RPH-104
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial
Drug:
Placebo
Normal Saline (0.9% Sodium Chloride solution)

Locations

Country Name City State
Russian Federation Clinic of Nephrology, Internal and Occupational Diseases. EAT. Tareeva, University Clinical Hospital No. 3 Moscow
Russian Federation Research Institute of Rheumatology. V.A. Nasonova Moscow
Russian Federation FGBU "National Medical Research Center named after V.A. Almazov", Ministry of Health of the Russian Federation, Department of Rheumatology St. Petersburg
Russian Federation State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital, Department of Rheumatology St. Petersburg

Sponsors (5)

Lead Sponsor Collaborator
R-Pharm International, LLC Data Management 365, Exacte Labs LLC, Federal State Budgetary Educational Institution for Higher Education FSPbSMU n. a. I.P. Pavlov of the Ministry of Health of the Russian Federation, Scientific Center EFiS LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time (number of days) to exacerbation during 24 weeks after randomization while taking RPH-104 vs placebo in patients with AOSD The criteria for exacerbation are (more than 2 criteria or worsening of more than 2 previous criteria):
fever (body temperature = 38.0 °C) due to AOSD during a week before the visit;
rash typical of AOSD;
clinical disease activity index (CDAI) > 2.8 for subjects with inactive disease; > 10 for subjects with low disease activity*;
sore throat*;
pericardial effusion = 7 mm*;
pleuritis*;
chest pain > 3 numeric rating scale (NRS)*;
C-reactive protein (CRP) > 5 mg/L*;
aminotransferase (ALT, AST) level > 3 x upper limits of normal (ULN)*;
leukocyte count > 10 x 10^9/L with > 80 % polymorphonuclear neutrophils*;
ferritin level > 3 x ULN*;
Patient's Global Assessment (PtGA) worsening by 2 cm and more;
Physician's Global Assessment (PGA) worsening by 2 cm and more;
myalgia*;
hepatomegaly*;
splenomegaly*;
lymphadenopathy*. * Increase/presence of noted signs due to other reason than AOSD should not be considered in the activity assessment for AOSD exacerbation.
from randomization (visit 16, week 29) to exacerbation, up to week 53
Secondary Proportion of patients from RPH-104 group who developed AOSD exacerbation during 24 weeks after randomization vs placebo The criteria for exacerbation are (more than two criteria or worsening of more than two previous criteria):
fever, i. e. body temperature = 38.0 °C due to AOSD lasting at least two consecutive days;
rash typical of AOSD;
sore throat*;
pericardial effusion = 7 mm*;
pleuritis*;
aminotransferase (ALT, AST) level > 3 x ULN*;
leukocyte count > 15 x 10^9/L*;
ferritin level > 3 x ULN*;
myalgia*;
hepatomegaly*;
splenomegaly*;
lymphadenopathy*;
pneumonia*;
arthritis*. * Increase/presence of noted signs due to other reason than AOSD should not be considered in the activity assessment for AOSD exacerbation.
up to week 53
Secondary Proportion of patients who developed AOSD exacerbation during the run-in period The criteria for exacerbation are (more than two criteria or worsening of more than two previous criteria):
fever, i. e. body temperature = 38.0 °C due to AOSD lasting at least two consecutive days;
rash typical of AOSD;
sore throat*;
pericardial effusion = 7 mm*;
pleuritis*;
aminotransferase (ALT, AST) level > 3 x ULN*;
leukocyte count > 15 x 10^9/L*;
ferritin level > 3 x ULN*;
myalgia*;
hepatomegaly*;
splenomegaly*;
lymphadenopathy*;
pneumonia*;
arthritis*. * Increase/presence of noted signs due to other reason than AOSD should not be considered in the activity assessment for AOSD exacerbation.
up to week 29
Secondary Proportion of patients with fever resolution Proportion of patients with fever resolution during the run-in treatment period.
Fever resolution means body temperature < 38.0 °C
up to Day 14
Secondary Proportion of patients with Simple disease activity index (SDAI) = 3.3 Proportion of patients with SDAI = 3.3 during the run-in treatment period.
SDAI is the sum of five parameters:
Physician's Global Assessment (PGA) and
Patient's Global Assessment (PtGA)
C-Reactive Protein (CRP) level*
Number of joints with active arthritis (based on an assessment of 28 joints): Tender Joint Count (TJC) (0-28) + Swollen Joint Count (SJC) (0-28) + PtGA (Visual analogue scale (VAS) in cm) + PGA (VAS) + CRP (mg/dl) The maximum score is 86 with high disease activity (the worst outcome). *Another cause for the elevated CRP must be ruled out.
up to Day 203
Secondary Proportion of patients with CDAI 3.3 - 11 Proportion of patients with CDAI 3.3 - 11 during the run-in treatment period.
CDAI will be calculated using the following formula: CDAI = tender joint number (TJN) (0-28) + swollen joint number (SJN) (0-28) + Patient Global Assessment of Disease Activity (Visual analogue scale (VAS) in cm) + Physician Global Assessment (VAS in cm).
CDAI Range: 0 - 76, with a decrease from baseline indicating improvement.
up to Day 203
Secondary Proportion of patients with a decrease in modified Pouchot score (mPouchot) score of at least 3 points or a decrease in mPouchot score of at least 1 point, provided that mPouchot score =4 at baseline (Day 0), during the run-in treatment period mPouchot score is calculated by assigning 1 point to each of these items:
fever (body temperature = 38.0 °C due to AOSD);
rash typical of AOSD (according to data of physical examination);
number of joints with active arthritis (0 to 68/66 joints)*;
sore throat (according to complaints as of examination)*;
pericardial effusion (Echocardiography)*;
pleuritis (ultrasound examination of the lungs)*;
aminotransferase (ALT, AST) activity*;
leukocyte count*;
ferritin level*;
myalgia (according to complaints as of examination)*;
hepatomegaly (ultrasound examination of the abdominal organs)*;
lymphadenopathy (physical examination)*;
Pneumonia (chest X-ray data)*. The maximum score is 12 points with high disease activity (the worst outcome). Hepatomegaly and aminotransferase levels are 1 point.
For noted signs, which are not AOSD-specific, other reason for their increase/presence should be considered in the activity assessment for AOSD exacerbation.
up to Day 203
Secondary Proportion of patients with clinically significant reduction in joint manifestations Proportion of patients with clinically significant reduction in joint manifestations - SDAI reduced by at least 7 points from baseline (Day 0), during the run-in treatment period. up to Day 203