- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05462522
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
May 2, 2024 updated by: Genentech, Inc.
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: GA43360 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Buenos Aires, Argentina, B1888AAE
- Recruiting
- Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.
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Estomba, Argentina, C1430EGF
- Recruiting
- Clinica Adventista Belgrano
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Munro Buenos Aires, Argentina, 1605
- Recruiting
- Clinica Privada Independencia
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San Miguel de Tucumán, Argentina, T4000IHE
- Recruiting
- Clinica Mayo de U.M.C.B. S.R.L
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Leuven, Belgium, 3000
- Recruiting
- UZ Leuven
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Liège, Belgium, 4000
- Recruiting
- CHU de Liege
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La Tronche, France, 38700
- Recruiting
- Centre Hospitalier Universitaire de Grenoble - Albert Michallon
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Paris, France, 75014
- Recruiting
- Hôpital Cochin
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Pessac, France, 33600
- Recruiting
- CHU de Bordeaux
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Rennes, France, 35000
- Recruiting
- CHRU Rennes
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Strasbourg, France, 67200
- Recruiting
- Hopitaux Universitaires
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Toulouse, France, 31000
- Recruiting
- Hopital Purpan
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Dresden, Germany, 01307
- Withdrawn
- Universitaetsklinikum Carl Gustav Carus an der TU Dresden
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Freiburg, Germany, 79106
- Recruiting
- Universitätsklinikum Freiburg
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Haifa, Israel, 3109601
- Recruiting
- Rambam Medical Center - PPDS
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Haifa, Israel, 34362
- Recruiting
- Lady Davis Carmel Medical Center
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Kfar Saba, Israel, 4428164
- Recruiting
- Meir Medical Center; Rheumatology Dept
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Ramat Gan, Israel, 5266202
- Recruiting
- Sheba Medical Center - PPDS
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Bydgoszcz, Poland, 85-168
- Recruiting
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Klinika Reumatologii
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Kraków, Poland, 31-121
- Recruiting
- Szpital Specjalistyczny im. Jozefa Dietla w Krakowie
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Lublin, Poland, 20-607
- Recruiting
- Zespol Poradni Specjalistycznych REUMED
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Nadarzyn, Poland, 05-830
- Recruiting
- Lecznica MAK-MED NZOZ
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Warszawa, Poland, 02-637
- Recruiting
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
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Almada, Portugal, 2801-915
- Recruiting
- Hospital Garcia de Orta
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Coimbra, Portugal, 3000-075
- Recruiting
- Centro Hospitalar E Universitário de Coimbra EPE
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San Juan, Puerto Rico, 00935-0001
- Recruiting
- The Alliance Medical Sciences Campus; University Hospital
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Belgrade, Serbia, 11000
- Recruiting
- Institute of Rheumatology Belgrade - PPDS
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario Vall d Hebron
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Barcelona, Spain, 08025
- Recruiting
- Hospital de la Santa Creu i Sant Pau
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Cordoba, Spain, 14004
- Recruiting
- C.H. Regional Reina Sofia - PPDS
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Sevilla, Spain, 41010
- Recruiting
- Hospital Quironsalud Infanta Luisa
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Sevilla, Spain, 41013
- Withdrawn
- Hospital Universitario Virgen Del Rocio
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Badajoz
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Merida, Badajoz, Spain, 06800
- Recruiting
- Hospital de Merida
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London, United Kingdom, NW3 2QG
- Recruiting
- Royal Free Hospital; Haematology
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Salford, United Kingdom, M6 8HD
- Recruiting
- Salford Royal Hospital
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California
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Palo Alto, California, United States, 94304-1808
- Active, not recruiting
- Stanford University
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Recruiting
- MedStar Georgetown University Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02114-2621
- Recruiting
- Massachusetts General Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic - Cancer Center - Rochester - PPDS
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New York
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New York, New York, United States, 10021-4823
- Recruiting
- Hospital for Special Surgery
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Ohio
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Toledo, Ohio, United States, 43614
- Withdrawn
- University of Toledo Medical Center
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Texas
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Dallas, Texas, United States, 75235-6262
- Completed
- Metroplex Clinical Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MAD Stage
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.
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RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.
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Experimental: OSE Stage
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.
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RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 17 months
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Up to approximately 17 months
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame: Up to approximately 17 months
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Up to approximately 17 months
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Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results
Time Frame: Up to approximately 17 months
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Up to approximately 17 months
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Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time Frame: Up to approximately 17 months
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Up to approximately 17 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Predose on Day 1 and at multiple timepoints up to Day 113 or early termination (ET) visit
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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
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Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
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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
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Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
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MAD Stage: Total Clearance (CL) of RO7303509
Time Frame: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
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Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
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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
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Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
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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
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Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
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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)
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2023
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
November 28, 2025
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
May 3, 2024
Last Update Submitted That Met QC Criteria
May 2, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA43360
- 2021-004578-68 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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