Back to resultsA Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
Primary Purpose
Systemic Sclerosis
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7303509
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria for the MAD Stage:
- Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration
- Participants with diffuse cutaneous systemic sclerosis (dcSSc), ≥ 15 modified Rodnan Skin Score (mRSS) units or with limited cutaneous systemic sclerosis (lcSSc), ≥ 9 mRSS units
- Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential
Inclusion Criteria for the OSE Stage:
- No clinically significant change in eligibility status
- Completion of the MAD and ability to roll over into the OSE within 72 hours
Exclusion Criteria:
- Active rheumatic autoimmune disease other than SSc requiring treatment with disease-modifying therapy
- Pulmonary disease with forced vital capacity (FVC) ≤ 50% of predicted
- History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Immunization with a live/attenuated vaccine within 4 weeks prior to initiation of study drug or planned during study
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of study drug
- History of solid organ or stem-cell transplantation
- Major surgery within 8 weeks prior to screening, or major planned surgery during the study or within 3 months after the final dose
- Positive hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody test at screening
- Serious infection requiring oral or intravenous (IV) antibiotics within 14 days prior to initiation of study drug or IV antibiotics within 28 days prior to initiation of study drug
- Any serious medical condition or abnormality in clinical laboratory tests
Sites / Locations
- Stanford UniversityRecruiting
- Medstar Georgetown University HospitalRecruiting
- Massachusetts General HospitalRecruiting
- Mayo Clinic - Cancer Center - Rochester - PPDSRecruiting
- University of Toledo Medical Center
- Metroplex Clinical Research Centre
- Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.Recruiting
- Clinica Mayo de U.M.C.B. S.R.LRecruiting
- UZ LeuvenRecruiting
- CHU de LiègeRecruiting
- Centre Hospitalier Universitaire de Grenoble - Albert MichallonRecruiting
- Hopital CochinRecruiting
- CHU de BordeauxRecruiting
- CHRU RennesRecruiting
- Hopitaux UniversitairesRecruiting
- Hopital PurpanRecruiting
- Universitätsklinikum Carl Gustav Carus an der TU DresdenRecruiting
- Rambam Medical Center - PPDSRecruiting
- Lady Davis Carmel Medical CenterRecruiting
- Meir Medical Center; Rheumatology DeptRecruiting
- Sheba Medical Center - PPDSRecruiting
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Klinika ReumatologiiRecruiting
- Szpital Specjalistyczny im. Jozefa Dietla w KrakowieRecruiting
- Zespol Poradni Specjalistycznych REUMEDRecruiting
- Lecznica MAK-MED NZOZRecruiting
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory ReicherRecruiting
- Hospital Garcia de OrtaRecruiting
- Centro Hospitalar E Universitário de Coimbra EPERecruiting
- The Alliance Medical Sciences Campus; University HospitalRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitario Vall d HebronRecruiting
- C.H. Regional Reina Sofia - PPDSRecruiting
- Hospital Quironsalud Infanta LuisaRecruiting
- Hospital Universitario Virgen del Rocio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MAD Stage
OSE Stage
Arm Description
Participants will be randomized in a ratio of 4:1 to receive RO7303509 or placebo, as subcutaneous (SC) injection, one time per month for 3 months. You have a 20% chance of getting placebo.
Every participant in the OSE stage will receive study drug and no participant will receive placebo. Participants will receive RO7303509 as SC injection at the same dose as that administered during the MAD stage, one time per month for up to a year.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Secondary Outcome Measures
MAD Stage: Maximum Serum Concentration (Cmax) of RO7303509
MAD Stage: Area Under the Concentration vs Time Curve (AUC) of RO7303509
MAD Stage: Time to Maximum Concentration (Tmax) of RO7303509
MAD Stage: Total Clearance (CL) of RO7303509
MAD Stage: Volume of Distribution (V) of RO7303509
MAD Stage: Half-Life (t1/2) of RO7303509
MAD and OSE Stage: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7303509
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05462522
Brief Title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
Official Title
A Phase Ib, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of RO7303509 in Participants With Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
March 14, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MAD Stage
Arm Type
Experimental
Arm Description
Participants will be randomized in a ratio of 4:1 to receive RO7303509 or placebo, as subcutaneous (SC) injection, one time per month for 3 months. You have a 20% chance of getting placebo.
Arm Title
OSE Stage
Arm Type
Experimental
Arm Description
Every participant in the OSE stage will receive study drug and no participant will receive placebo. Participants will receive RO7303509 as SC injection at the same dose as that administered during the MAD stage, one time per month for up to a year.
Intervention Type
Drug
Intervention Name(s)
RO7303509
Intervention Description
RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to approximately 17 months
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame
Up to approximately 17 months
Title
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results
Time Frame
Up to approximately 17 months
Title
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time Frame
Up to approximately 17 months
Secondary Outcome Measure Information:
Title
MAD Stage: Maximum Serum Concentration (Cmax) of RO7303509
Time Frame
Predose on Day 1 and at multiple timepoints up to Day 113 or early termination (ET) visit
Title
MAD Stage: Area Under the Concentration vs Time Curve (AUC) of RO7303509
Time Frame
Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
Title
MAD Stage: Time to Maximum Concentration (Tmax) of RO7303509
Time Frame
Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
Title
MAD Stage: Total Clearance (CL) of RO7303509
Time Frame
Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
Title
MAD Stage: Volume of Distribution (V) of RO7303509
Time Frame
Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
Title
MAD Stage: Half-Life (t1/2) of RO7303509
Time Frame
Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
Title
MAD and OSE Stage: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7303509
Time Frame
MAD Stage: Predose on Day 1 and at multiple timepoints up to Day 113 (Week 16) or ET visit; OSE Stage: Predose and multiple timepoints up to Week 52; (up to approximately 1.3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria for the MAD Stage:
Weight of 45-150 kg at screening
Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration from first non-Raynaud's symptom
Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential for 4 months after last dose of study drug
Inclusion Criteria for the OSE Stage:
No clinically significant change in eligibility status
Completion of the MAD and ability to roll over into the OSE within 5 days
Exclusion Criteria:
Active rheumatic autoimmune disease other than SSc requiring treatment with disease-modifying therapy
Pulmonary disease with forced vital capacity (FVC) ≤ 50% of predicted
History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of study drug
Major surgery within 8 weeks prior to screening, or major planned surgery during the study or within 3 months after the final dose
Positive hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody test at screening
Any serious medical condition or abnormality in clinical laboratory tests
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GA43360 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1808
Country
United States
Individual Site Status
Recruiting
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2621
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic - Cancer Center - Rochester - PPDS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Withdrawn
Facility Name
Metroplex Clinical Research Centre
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-6262
Country
United States
Individual Site Status
Completed
Facility Name
Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.
City
Buenos Aires
ZIP/Postal Code
B1888AAE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Mayo de U.M.C.B. S.R.L
City
San Miguel de Tucumán
ZIP/Postal Code
T4000IHE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopitaux Universitaires
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center - PPDS
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center; Rheumatology Dept
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center - PPDS
City
Ramat-Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Klinika Reumatologii
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny im. Jozefa Dietla w Krakowie
City
Kraków
ZIP/Postal Code
31-121
Country
Poland
Individual Site Status
Recruiting
Facility Name
Zespol Poradni Specjalistycznych REUMED
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Recruiting
Facility Name
Lecznica MAK-MED NZOZ
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2801-915
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
The Alliance Medical Sciences Campus; University Hospital
City
San Juan
ZIP/Postal Code
00935-0001
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
C.H. Regional Reina Sofia - PPDS
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Quironsalud Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual participant level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
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