Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

August 23, 2023

Primary Completion Date

April 9, 2027

Study Completion Date

December 25, 2028

Conditions
Lung Diseases, Interstitial
Interventions
DRUG

Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)

Olokizumab is a sterile solution for subcutaneous injection in a 2-mL clear Type I glass vial, containing a target fill volume of 0.5 mL (for withdrawal of no less than 0.4 mL) of olokizumab drug substance at a concentration of 160 milligrams (mg)/mL.

DRUG

SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL

Placebo (sodium chloride 0.9 %) does not contain any active pharmaceutical ingredients. Placebo will be supplied in 2-mL, 5-mL, or 10-mL ampoules made of low-density polyethylene or polypropylene.

Trial Locations (33)

109240

RECRUITING

City Clinical Hospital named after Davydovsky I.V., Moscow

111123

RECRUITING

GBUZ Moscow Clinical Scientific Center named after Loginov MHD, Moscow

115522

RECRUITING

Scientific Research Institute of Reumatology named after Nasonova V.A, Moscow

117546

RECRUITING

Moscow City Polyclinic №52, Moscow

119048

RECRUITING

Clinical Hospital №4 of Sechenov University, Moscow

119435

RECRUITING

Clinical Hospital №3 of Sechenov University, Moscow

123182

RECRUITING

"State Budgetary Healthcare Institution of Moscow City City Clinical Hospital №52 of the Moscow City Health Department, Consultative and diagnostic department №2", Moscow

RECRUITING

"State Budgetary Healthcare Institution of Moscow City City Clinical Hospital №52 of the Moscow City Health Department", Moscow

127473

RECRUITING

"FSBEI HE Russian University of Medicine, MoH of Russia", Moscow

129110

RECRUITING

"Moscow Regional Research and Clinical Institute MONIKI", Moscow

139036

RECRUITING

Saint-Petersburg State Research Institute of Phthisiopulmonology of the Ministry of Healthcare of the Russian Federation, Saint Petersburg

150003

RECRUITING

Clinical Hospital of Emergency Medical Care named after Solovyov N.V, Yaroslavl

185019

RECRUITING

Republican Hospital named after V.A. Baranov, Petrozavodsk

188300

RECRUITING

"State budgetary healthcare institution of the Leningrad region Gatchina Clinical Interdistrict Hospital", Gatchina

194156

RECRUITING

"LLCEnergy of Health", Saint Petersburg

194214

RECRUITING

"Medical Center Interleukin", Saint Petersburg

194354

RECRUITING

City Multidisciplinary Hospital №2-Expert Center in the field of Pulmonology, Saint Petersburg

214006

RECRUITING

"Regional state budgetary healthcare institution Clinical Hospital No. 1", Smolensk

350086

RECRUITING

State Budgetary Healthcare Institution Research Institute-Karpaty Clinical Hospital No. 1 named after prof. S.V. Ochapovsky, Krasnodar

394066

RECRUITING

"Budgetary healthcare institution of the Voronezh region Voronezh Regional Clinical Hospital No1", Voronezh

410053

RECRUITING

"State Healthcare Institution Regional Clinical Hospital", Saratov

420094

RECRUITING

"LLC Scientific Research Medical Complex Your Health", Kazan'

450008

RECRUITING

"Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University of the Ministry of Health of the Russian Federation", Ufa

454001

RECRUITING

Regional Clinic Hospital№3, Chelyabinsk

454048

RECRUITING

Chelyabinsk Regional Clinical Hospital, Chelyabinsk

600023

RECRUITING

"State Budgetary Healthcare Institution of the Vladimir Region Regional Clinical Hospital", Vladimir

620039

RECRUITING

Ural research Institute of Phthisiopulmonology, Yekaterinburg

630117

RECRUITING

Federal Research Center Institute of Cytologyand Genetics,Siberian Branch of Russian Academy of Sciences, Novosibirsk

634040

RECRUITING

"Regional State Budgetary Healthcare Institution Medical and Sanitary Unit No. 2", Tomsk

650000

RECRUITING

Kuzbass Clinical Hospital Emergency Medical Care named after Podgorbunsky M.A, Kemerovo

656024

RECRUITING

Regional Clinical Hospital Regional state budgetary healthcare institution, Barnaul

426011,

RECRUITING

"LLC Medsi-Izhevsk", Izhevsk

196240,

RECRUITING

"LLCKurator", Saint Petersburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

R-Pharm

INDUSTRY

collaborator

Exacte Labs LLC

INDUSTRY

collaborator

Data Management 365

INDUSTRY

collaborator

Keystat, LLC

INDUSTRY

lead

R-Pharm International, LLC

INDUSTRY

NCT06440746 - Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases | Biotech Hunter | Biotech Hunter