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Active, not recruitingNCT05835986Updated Oct 2, 2026

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

A Phase 1 interventional study of RO7507062 and Tocilizumab in Systemic Lupus Erythematosus, sponsored by Hoffmann-La Roche. Active, not recruiting at 18 sites in 13 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Updated Oct 2, 20261 site removedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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). 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).

02

Conditions studied

  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Part 1: SAD: RO7507062

    Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1.

    Drug: RO7507062 · Drug: Tocilizumab

  • Experimental
    Part 2: Dose Escalation with Fractionated Dosing: RO7507062

    Participants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days.

    Drug: RO7507062 · Drug: Tocilizumab

Interventions

  • DrugRO7507062

    RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).

  • DrugTocilizumab

    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.

    Also known as: Actemra, RoActemra

06

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs)

    Time frame: Day 1 through Day 29

  2. 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

  3. 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.

    Time frame: Up to approximately 12 months

Secondary outcomes

  1. Serum Concentration of RO7507062

    Time frame: Up to approximately 12 months

  2. Time to Maximum Serum Concentration (Tmax) of RO7507062

    Time frame: Up to approximately 12 months

  3. Maximum Serum Concentration (Cmax) of RO7507062

    Time frame: Up to approximately 12 months

  4. Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7507062

    Time frame: Up to approximately 12 months

  5. 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

  6. Apparent Terminal Half-Life (T1/2) of RO7507062

    Time frame: Up to approximately 12 months

  7. Terminal Rate Constant (λz) of RO7507062

    Time frame: Up to approximately 12 months

  8. Apparent Volume of Distribution (Vz/F) of RO7507062

    Time frame: Up to approximately 12 months

  9. Apparent Total Body Clearance (CL/F) of RO7507062

    Time frame: Up to approximately 12 months

  10. Number of Participants with Anti-Drug Antibodies (ADAs) to RO7507062

    Time frame: Up to approximately 12 months

07

Study locations

18 sites
  • Clinica De La Costa
    Barranquilla, 080020, Colombia
  • Hospital Pablo Tobon Uribe
    Medellín, 050034, Colombia
  • Groupe Hospitalier Pitie-Salpetriere
    Paris, 75651, France
  • Charité Research Organisation GmbH
    Berlin, 10117, Germany
  • Hospital Umum Sarawak
    Kuching, 93586, Malaysia
  • CREA Hospital Mexico Americano
    Guadalajara, Jalisco 44620, Mexico
  • Hospital Angeles De Lindavista
    Mexico City, Mexico CITY (federal District) 07760, Mexico
  • Hospital General De Mexico
    Mexico City, Mexico CITY (federal District) 6726, Mexico
  • Centre For Human Drug Research
    Leiden, 2333, Netherlands
  • Clínica San Juan Bautista CSJB
    Lima, 15431, Peru
  • Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy
    Warsaw, 04-141, Poland
  • FARMOVS (Pty) Ltd
    Bloemfontein, 9301, South Africa
  • Hospital General Universitario Gregorio Marañon
    Madrid, 28007, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Chung Shan Medical University Hospital
    Taichung, 40201, Taiwan
  • Chang Gung Medical Foundation - Linkou
    Taoyuan, 333, Taiwan
  • Ramathibodi Hospital, Mahidol Uni
    Bangkok, 10400, Thailand
  • UCL Hospital NHS Trust
    London, NW1 2PG, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site removed
Show 1 removed
  • Oncomedica S.A. · Montería, Colombia
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    1 site removed
    Show 1 removed
    • Oncomedica S.A. · Montería, Colombia
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05835986
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 28, 2023
Start date
Dec 18, 2023
Primary completion
Nov 30, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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