Systemic Lupus ErythematosusPhase 1NCT05835986
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
A Phase 1 study testing RO7507062 and Tocilizumab in people with Systemic Lupus Erythematosus, run by Hoffmann-La Roche at 18 sites in 13 countries.
Trial summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- RO7507062 and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 18 sitesin 13 countries
- Study dates
- 18 Dec 2023to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria at least 24 weeks prior to Screening and should have been treated for SLE according to standard clinical practice.
- Presence of anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP) or anti-Sjögren's syndrome antigen A (SS-A) above the upper limit of normal (ULN); or, positive anti-nuclear antibody (ANA; ≥ 1:160).
- Active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score of ≥4 with at least 1 positive clinical item.
- For participants receiving oral corticosteroids (OCS), treatment with ≤ 20 milligram per day (mg/day) prednisone or equivalent, during Screening, at a dose that has been stable for at least 7 days prior to Day 1.
- For participants receiving conventional immunosuppressants (e.g., azathioprine, sulfasalazine, mycophenolate mofetil [≤ 3.0 grams per day], mycophenolic acid [≤ 3 grams per day], methotrexate [oral, SC, or intramuscular routes]), and calcineurin inhibitors [oral]), treatment should be at a stable dose for at least 6 weeks prior to Screening and during Screening and expected to remain stable during the study.
Who cannot join
- Active or unstable lupus-associated neuropsychiatric disease.
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to Screening or during Screening.
- Presence of severe lupus-associated renal disease that is likely to require treatment with cyclophosphamide, B-cell-depleting therapies, other biologic or targeted therapies.
- Organ-threatening SLE manifestations (e.g., active myocarditis) considered to be severe by the Investigator.
- Severe active systemic autoimmune disease other than SLE.
- Active infection of any kind, excluding fungal infection of the nail beds.
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- History of serious recurrent or chronic infection, especially; recurring, chronic infections specifically related to respiratory issues.
- Moderate or severe chronic obstructive pulmonary disease (COPD).
- History of progressive multifocal leukoencephalopathy (PML).
- History of macrophage-activation syndrome and/or hemophagocytic lymphohistiocytosis.
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the 5 years prior to the Screening visit (with the exception of basal cell carcinoma, non melanoma skin cancer, and cervical cancer in situ, if these have been adequately treated and are considered cured).
- Intolerance or contraindication to study therapies including history of severe allergic or anaphylactic reactions to monoclonal antibodies (mAbs) or known hypersensitivity to any component of the RO7507062 injection.
- History of infection with hepatitis B virus (HBV), or positive serology indicative of current or past HBV infection.
- Human immunodeficiency virus (HIV; positive HIV antibody test) and active hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]).
- Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection.
- Receipt of any anti- cluster of differentiation (CD)19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab less than 6 months prior to screening or during screening.
- Receipt of Inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2 including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, and fenebrutinib,or any investigational agent within 30 days prior to screening or during screening.
- Receipt of Cyclophosphamide or a biologic therapy such as, but not limited to, adalimumab, etanercept, golimumab, infliximab, belimumab,ustekinumab, anifrolumab, secukinumab, or atacicept, within 4 weeks prior to enrollment.
- Active tuberculosis or history of recurring or severe active tuberculosis, or a positive Interferon Gamma Release Assay (IGRA). Latent tuberculosis which has been treated prior to baseline is not exclusive.
- Receipt of an investigational therapy (except severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] vaccines) within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study.
- Immunoglobulin (IgG) level of <6 gram per liter (g/L).
- Estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73-meter square (m^2).
Trial locations and contacts
18 sites in 13 countries.
18 sites in 13 countries
Mexico3 sites
CREA Hospital Mexico Americano
Guadalajara, Jalisco, 44620
Hospital Angeles De Lindavista
Mexico City, Mexico CITY (federal District), 07760
Hospital General De Mexico
Mexico City, Mexico CITY (federal District), 6726
Colombia2 sites
Clinica De La Costa
Barranquilla, 080020
Hospital Pablo Tobon Uribe
Medellín, 050034
Spain2 sites
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Taiwan2 sites
Chung Shan Medical University Hospital
Taichung, 40201
Chang Gung Medical Foundation - Linkou
Taoyuan, 333
Poland1 site
Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy
Warsaw, 04-141
About this study
Official title: An Open-label, Multicenter, Dose Escalation, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered RO7507062 in Participants With Systemic Lupus Erythematosus
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.
Read the detailed description
Tocilizumab is an additional investigational medicinal product (IMP), which may be used at the investigator's discretion when required in case of clinical presentation of cytokine release syndrome (CRS).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- RO7507062, Tocilizumab
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7507062Drug
RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
TocilizumabDrug
Also called Actemra, RoActemra
When applicable, tocilizumab solution for infusion will be administered intravenously at 8 milligram per kilogram (mg/kg) for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD: RO7507062 | Experimental | Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1. Receives: Drug: RO7507062; Drug: Tocilizumab |
| Part 2: Dose Escalation with Fractionated Dosing: RO7507062 | Experimental | Participants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days. Receives: Drug: RO7507062; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs)
Measured: Day 1 through Day 29
Part 2: Fractionated Dose Cohort: Number of Participants with DLAEs
Measured: Day 1 through to the end of the 28-day safety evaluation period
Number of Participants with Adverse Events (AEs)
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and CRS, will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.
Measured: Up to approximately 12 months
Secondary outcomes (10)
Serum Concentration of RO7507062
Measured: Up to approximately 12 months
Time to Maximum Serum Concentration (Tmax) of RO7507062
Measured: Up to approximately 12 months
Maximum Serum Concentration (Cmax) of RO7507062
Measured: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7507062
Measured: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of RO7507062
Measured: Up to approximately 12 months
Apparent Terminal Half-Life (T1/2) of RO7507062
Measured: Up to approximately 12 months
Terminal Rate Constant (λz) of RO7507062
Measured: Up to approximately 12 months
Apparent Volume of Distribution (Vz/F) of RO7507062
Measured: Up to approximately 12 months
Apparent Total Body Clearance (CL/F) of RO7507062
Measured: Up to approximately 12 months
Number of Participants with Anti-Drug Antibodies (ADAs) to RO7507062
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start18 Dec 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835986
- Sponsor's protocol ID
- BP44315
- Other IDs
- 2022-502632-39-00
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Dose Escalation, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered RO7507062 in Participants With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05835986
- Acronym / sponsor ID
- BP44315
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Apr 2023 (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 investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.
Detailed description
Tocilizumab is an additional investigational medicinal product (IMP), which may be used at the investigator's discretion when required in case of clinical presentation of cytokine release syndrome (CRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD: RO7507062 | Experimental | Drug: RO7507062, Drug: TocilizumabParticipants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1. |
| Part 2: Dose Escalation with Fractionated Dosing: RO7507062 | Experimental | Drug: RO7507062, Drug: TocilizumabParticipants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have a diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria at least 24 weeks prior to Screening and should have been treated for SLE according to standard clinical practice.
- Presence of anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP) or anti-Sjögren's syndrome antigen A (SS-A) above the upper limit of normal (ULN); or, positive anti-nuclear antibody (ANA; ≥ 1:160).
- Active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score of ≥4 with at least 1 positive clinical item.
- For participants receiving oral corticosteroids (OCS), treatment with ≤ 20 milligram per day (mg/day) prednisone or equivalent, during Screening, at a dose that has been stable for at least 7 days prior to Day 1.
- For participants receiving conventional immunosuppressants (e.g., azathioprine, sulfasalazine, mycophenolate mofetil [≤ 3.0 grams per day], mycophenolic acid [≤ 3 grams per day], methotrexate [oral, SC, or intramuscular routes]), and calcineurin inhibitors [oral]), treatment should be at a stable dose for at least 6 weeks prior to Screening and during Screening and expected to remain stable during the study.
Key exclusion criteria (22 listed)
- Active or unstable lupus-associated neuropsychiatric disease.
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to Screening or during Screening.
- Presence of severe lupus-associated renal disease that is likely to require treatment with cyclophosphamide, B-cell-depleting therapies, other biologic or targeted therapies.
- Organ-threatening SLE manifestations (e.g., active myocarditis) considered to be severe by the Investigator.
- Severe active systemic autoimmune disease other than SLE.
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 |
|---|---|---|
| RO7507062RO7507062 solution for injection will be administered SC as specified in each treatment part (arm). | Drug | Part 1: SAD: RO7507062, Part 2: Dose Escalation with Fractionated Dosing: RO7507062 |
| TocilizumabAlso: Actemra, RoActemraWhen applicable, tocilizumab solution for infusion will be administered intravenously at 8 milligram per kilogram (mg/kg) for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg. | Drug | Part 1: SAD: RO7507062, Part 2: Dose Escalation with Fractionated Dosing: RO7507062 |
Primary outcome
Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs)
Time frame: Day 1 through Day 29
Part 2: Fractionated Dose Cohort: Number of Participants with DLAEs
Time frame: Day 1 through to the end of the 28-day safety evaluation period
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 12 months
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and CRS, will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.
10 secondary outcomes
Serum Concentration of RO7507062
Time frame: Up to approximately 12 months
Time to Maximum Serum Concentration (Tmax) of RO7507062
Time frame: Up to approximately 12 months
Maximum Serum Concentration (Cmax) of RO7507062
Time frame: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7507062
Time frame: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of RO7507062
Time frame: Up to approximately 12 months
Apparent Terminal Half-Life (T1/2) of RO7507062
Time frame: Up to approximately 12 months
Terminal Rate Constant (λz) of RO7507062
Time frame: Up to approximately 12 months
Apparent Volume of Distribution (Vz/F) of RO7507062
Time frame: Up to approximately 12 months
Apparent Total Body Clearance (CL/F) of RO7507062
Time frame: Up to approximately 12 months
Number of Participants with Anti-Drug Antibodies (ADAs) to RO7507062
Time frame: Up to approximately 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- 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
18 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7507062 and Tocilizumab in people with Systemic Lupus Erythematosus, run by Hoffmann-La Roche at 18 sites in 13 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 22 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Mexico, Colombia, Spain, Taiwan, France and 8 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?
This study is still under way. Results are not available in the source record yet.
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?
Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs) (time frame: Day 1 through Day 29). The study lists 3 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 2 Oct 2026.