Actively Recruiting
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
Led by Hoffmann-La Roche · Updated on 2026-05-11
70
Participants Needed
24
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with systemic lupus erythematosus (SLE) according to 2019 EULAR or ACR criteria at least 24 weeks before screening and treated per standard practice
- Presence of specific antibodies (anti-dsDNA, anti-Smith, anti-RNP, anti-SS-A) above normal or positive ANA at 1:160 or higher
- Active SLE with a SLEDAI-2K score of 4 or more and at least one positive clinical item
- If using oral corticosteroids, dose must be 20 mg/day prednisone or equivalent or less, stable for at least 7 days before Day 1
- If using certain immunosuppressants (azathioprine, sulfasalazine, mycophenolate mofetil, mycophenolic acid, methotrexate, calcineurin inhibitors), doses must be stable for at least 6 weeks before and during screening and expected to remain stable during the study
You will not qualify if you...
- Active or unstable lupus-related neuropsychiatric disease
- Catastrophic or severe antiphospholipid syndrome within 12 months before or during screening
- Severe lupus kidney disease likely requiring cyclophosphamide or biologic therapies
- Severe organ-threatening SLE manifestations such as active myocarditis
- Severe active systemic autoimmune diseases other than SLE
- Any active infection except fungal nail infections
- History of serious recurrent or chronic infections especially respiratory
- Moderate to severe chronic obstructive pulmonary disease (COPD)
- History of progressive multifocal leukoencephalopathy (PML)
- History of macrophage-activation syndrome or hemophagocytic lymphohistiocytosis
- History of cancer within 5 years except certain cured skin or cervical cancers
- Intolerance or allergy to study drugs or monoclonal antibodies
- History or current hepatitis B infection
- HIV positive or active hepatitis C infection
- Active cytomegalovirus or Epstein-Barr virus infection
- Receipt of anti-CD19 or anti-CD20 therapies within 6 months before screening
- Recent use of Janus kinase inhibitors, Bruton tyrosine kinase inhibitors, or investigational agents within 30 days before screening
- Recent use of cyclophosphamide or biologics within 4 weeks before enrollment
- Active or past severe tuberculosis or positive tuberculosis test (except treated latent TB)
- Immunoglobulin (IgG) level below 6 g/L
- Estimated glomerular filtration rate below 45 mL/min/1.73 m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Clinica De La Costa
Barranquilla, Colombia, 080020
Actively Recruiting
2
Hospital Pablo Tobon Uribe
Medellín, Colombia, 050034
Actively Recruiting
3
Oncomedica S.A.
Montería, Colombia, 230002
Actively Recruiting
4
Hôpital Saint Eloi
Montpellier, France, 34295
Actively Recruiting
5
Groupe Hospitalier Pitie-Salpetriere
Paris, France, 75651
Actively Recruiting
6
Charité Research Organisation GmbH
Berlin, Germany, 10117
Actively Recruiting
7
Universitätsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
8
Hospital Umum Sarawak
Kuching, Malaysia, 93586
Actively Recruiting
9
CREA Hospital Mexico Americano
Guadalajara, Jalisco, Mexico, 44620
Actively Recruiting
10
Hospital Angeles De Lindavista
Mexico City, Mexico CITY (federal District), Mexico, 07760
Actively Recruiting
11
Hospital General De Mexico
Mexico City, Mexico CITY (federal District), Mexico, 6726
Actively Recruiting
12
Centre For Human Drug Research
Leiden, Netherlands, 2333
Completed
13
Clínica San Juan Bautista CSJB
Lima, Peru, 15431
Actively Recruiting
14
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland, 61-848
Actively Recruiting
15
MICS Centrum Medyczne Damiana, Walbrzyska
Warsaw, Poland, 02-739
Withdrawn
16
Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy
Warsaw, Poland, 04-141
Actively Recruiting
17
FARMOVS (Pty) Ltd
Bloemfontein, South Africa, 9301
Actively Recruiting
18
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
19
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
20
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
21
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Actively Recruiting
22
Chang Gung Medical Foundation - Linkou
Taoyuan, Taiwan, 333
Actively Recruiting
23
Ramathibodi Hospital, Mahidol Uni
Bangkok, Thailand, 10400
Actively Recruiting
24
UCL Hospital NHS Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
B
BP44315 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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