ASSURO

• Research type

  Research Study

• Full title

  An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants with Rheumatoid Arthritis or Systemic Lupus Erythematosus

• IRAS ID

  1013043

• Contact name

  Sam Ringle

• Contact email

  sam.ringle@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Research summary

  This is a Phase 1, open-label clinical trial. Open-label means the participants, researchers, trial doctors, and other trial staff will know what each participant is receiving. In this trial, all participants will receive surovatamig. The trial will last up to about 1 year.
  This clinical trial will have up to 3 parts:
  In Part 1, the researchers will give participants different doses of surovatamig. The first group of participants will receive a single low dose of surovatamig. The results from these participants will be reviewed by the researchers before deciding whether to increase the dose for the next group of participants. This helps researchers to learn which dose is the best to use in further trials. Depending on the results from Part 1, the researchers may start Part 2.
  In Part 2, participants will each receive 2 doses of surovatamig. The doses will be given 7 days apart, and the second dose may be higher than the first dose. Depending on the results, the dose may be increased in the next group of participants in Part 2, or the researchers may start Part 3.
  In Part 3, participants will each receive 3 doses of surovatamig. The doses will be given 7 days apart, and each dose may be higher than the previous dose.
  Trial Population: This trial will include about 48 participants. To join this trial, people must be 18 to 65 years old and have RA or SLE.
  Treatments and Procedures: Surovatamig is given as an injection just under the skin, usually in the lower part of the stomach or in the thigh. For participants receiving more than 1 dose of surovatamig, the doses will be given 7 days apart and the injection will likely be given in a different part of the body than the previous dose. Participants will need to stay at the clinical trial site for 4 days and 3 nights after each dose of surovatamig.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  25/EE/0219

• Date of REC Opinion

  2 Dec 2025

• REC opinion

  Further Information Favourable Opinion