Systemic SclerosisPhase 1NCT05462522
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
A Phase 1 study testing RO7303509 in people with Systemic Sclerosis, run by Genentech, Inc. at 25 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- RO7303509
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 25 sitesin 11 countries
- Study dates
- 16 Jan 2023to 11 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- No clinically significant change in eligibility status
- Completion of the MAD and ability to roll over into the OSE within 5 days
Who cannot join
- 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
Trial locations and contacts
25 sites in 11 countries.
25 sites in 11 countries
France6 sites
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
La Tronche, 38700
Hopital Cochin
Paris, 75014
CHU de Bordeaux
Pessac, 33600
CHRU Rennes
Rennes, 35000
Hopitaux Universitaires
Strasbourg, 67200
Hopital Purpan
Toulouse, 31000
United States3 sites
Metroplex Clinical Research Centre
Dallas, Texas, 75235-6262
Hospital For Special Surgery
New York, New York, 10021-4823
Stanford University
Palo Alto, California, 94304
Spain3 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Vall d Hebron
Barcelona, 08035
Hospital Quironsalud Infanta Luisa
Seville, 41010
Argentina2 sites
Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.
Buenos Aires, B1888AAE
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, T4000IHE
Israel2 sites
Rambam Medical Center - PPDS
Haifa, 3109601
Meir Medical Center
Kfar Saba, 4428164
Poland2 sites
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Zespol Poradni Specjalistycznych REUMED
Lublin, 20-607
Portugal2 sites
Hospital Garcia de Orta
Almada, 2801-915
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, 3000-075
Serbia2 sites
Institute of Rheumatology Belgrade - PPDS
Belgrade, 11000
Military Medical Academy
Belgrade, 11040
Puerto Rico1 site
The Alliance Medical Sciences Campus
San Juan, 00935-0001
About this study
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
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.
- Conditions
- Systemic Sclerosis
- Being tested
- RO7303509, Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7303509Drug
RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
PlaceboDrug
RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.
| Study group | Role | What they receive |
|---|---|---|
| MAD Stage | Experimental | 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. Receives: Drug: RO7303509; Drug: Placebo |
| OSE Stage | Experimental | 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. Receives: Drug: RO7303509 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results
Measured: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Measured: Up to approximately 17 months
Secondary outcomes (7)
MAD Stage: Maximum Serum Concentration (Cmax) of RO7303509
Measured: Predose on Day 1 and at multiple timepoints up to Day 113 or early termination (ET) visit
MAD Stage: Area Under the Concentration vs Time Curve (AUC) of RO7303509
Measured: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Time to Maximum Concentration (Tmax) of RO7303509
Measured: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Total Clearance (CL) of RO7303509
Measured: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Volume of Distribution (V) of RO7303509
Measured: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD Stage: Half-Life (t1/2) of RO7303509
Measured: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
MAD and OSE Stage: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7303509
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start16 Jan 2023
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462522
- Sponsor's protocol ID
- GA43360
- Other IDs
- 2021-004578-68
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2022
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05462522
- Acronym / sponsor ID
- GA43360
- Conditions
- Systemic Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAD Stage | Experimental | Drug: RO7303509, Drug: PlaceboParticipants 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. |
| OSE Stage | Experimental | Drug: RO7303509Every 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- No clinically significant change in eligibility status
- Completion of the MAD and ability to roll over into the OSE within 5 days
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7303509RO7303509 will be administered as SC injection monthly, as specified in each treatment group. | Drug | MAD Stage, OSE Stage |
| PlaceboRO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage. | Drug | MAD Stage |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results
Time frame: Up to approximately 17 months
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Up to approximately 17 months
7 secondary outcomes
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
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
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
MAD Stage: Total Clearance (CL) of RO7303509
Time frame: Predose on Day 1 and at multiple timepoints up to Day 113 or ET visit
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
25 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7303509 in people with Systemic Sclerosis, run by Genentech, Inc. at 25 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, United States, Spain, Argentina, Israel and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to approximately 17 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.