you arrive at the clinic after having agreed to participate. during this visit a series of examinations are performed to record the current status of your disease.

blood samples are taken to measure laboratory values and to determine the concentration of daxdilimab if you receive the active drug.

the study medication is assigned in a double‑blind manner, meaning you will receive either daxdilimab or a placebo without knowing which one it is.

you receive a single subcutaneous injection of 300 mg of the assigned study medication. the injection is given under the skin by a health professional.

you continue to take your usual prednisone oral tablet, 20 mg once daily, as prescribed for your condition.

at each scheduled visit you undergo repeat assessments of disease activity, safety checks, and blood sampling.

you receive another subcutaneous injection of the same dose (300 mg) of the study medication, which may be daxdilimab or placebo according to the original randomisation.

you continue the daily intake of 20 mg prednisone tablets. the study protocol allows the investigator to adjust the prednisone dose only if a clinically meaningful reduction is achieved, as defined in the study criteria.

any side effects or new symptoms are recorded and evaluated by the study team.

this visit marks the main evaluation point of the trial. a comprehensive disease activity score (total improvement score) is measured and compared with the baseline value.

blood is drawn to assess the concentration of daxdilimab and to check for the presence of antibodies against the drug.

the amount of prednisone you are taking is reviewed. participants who were on a dose of at least 10 mg at baseline are evaluated for a reduction of at least 25 % or a final dose of 7.5 mg per day.

all adverse events that occurred during the study period are documented.

after the week‑24 assessment you may have additional safety visits according to the protocol, extending up to the overall study end date.

during these visits the focus is on monitoring long‑term safety, recording any delayed side effects, and performing final laboratory tests.

the study medication is no longer administered after the final scheduled injection, but you will continue any prescribed background therapy, such as prednisone, as directed by your physician.