A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis


About this study

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 12 weeks of RO7303509 treatment in patients with systemic sclerosis (SSc) during a multiple-ascending dose (MAD) portion of the trial.

The long-term safety and tolerability of up to 52 weeks of RO7303509 treatment will also be evaluated in an optional open-label safety extension (OSE).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Inclusion Criteria for the MAD Stage:

- Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European
League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration.

- Participants with diffuse cutaneous systemic sclerosis (dcSSc), ≥ 15 modified Rodnan
Skin Score (mRSS) units or with limited cutaneous systemic sclerosis (lcSSc), ≥ 9 mRSS

- Agreement to remain abstinent or use an effective contraceptive method among males and
females with childbearing potential.

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 72 hours.

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.

- Immunization with a live/attenuated vaccine within 4 weeks prior to initiation of
study drug or planned during study.

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
4 months after the final dose of study drug.

- History of solid organ or stem-cell transplantation.

- 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.

- Serious infection requiring oral or intravenous (IV) antibiotics within 14 days prior
to initiation of study drug or IV antibiotics within 28 days prior to initiation of
study drug.

- Any serious medical condition or abnormality in clinical laboratory tests.

Eligibility last updated 10/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ashima Makol, M.B.B.S.

Open for enrollment

Contact information:

Kathleen McCarthy-Fruin M.S.

(507) 284-4797


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