Badanie skuteczności i bezpieczeństwa GIA632 u dorosłych z vitiligo niesegmentalnym

Screening and baseline Assessment

After you sign the consent form, you attend a screening visit where your medical history is reviewed and a physical Examination is performed.

The severity of your nonsegmental vitiligo is measured using the facial vitiligo area Scoring Index (f-VASI) and the total body vitiligo area Scoring Index (T-VASI).

Blood samples may be taken to check general health before the study starts.

Randomization

Once you meet all eligibility Criteria, you are randomly assigned to receive either the investigational product gian632 or a matching placebo.

The assignment is double‑blind, which means neither you nor the study staff know which product you receive.

First dose administration

On the first treatment day you receive a subcutaneous injection of the assigned product.

The injection is given in the abdomen or thigh area using a pre‑filled syringe.

The exact dose is defined by the study protocol and is the same for all participants in the same treatment arm.

Regular dosing period (weeks 0‑24)

You receive the same subcutaneous injection at regular intervals as specified in the protocol (e.g., once every week).

The dosing continues for a total of 24 weeks.

Each visit includes a Brief safety check and recording of any side effects you may have experienced.

Interim efficacy assessments

At weeks 4, 12 and 24 you attend study visits where the investigator measures changes in your f-VASI and T-VASI scores.

The primary goal is to determine the percentage change in the f-VASI score from the start of treatment to week 24.

Extension period (weeks 24‑48)

After the primary 24‑week period you may continue receiving the same product for an additional 24 weeks, making the total treatment duration 48 weeks.

Follow‑up visits are scheduled at weeks 36 and 48 to repeat the efficacy and safety assessments.

Safety monitoring throughout the trial

At every visit you are asked about any new symptoms, and the study team records any treatment‑emergent adverse events (teae) or serious adverse events (sae).

Laboratory tests may be repeated to monitor your overall health.

Final study visit

At week 48 a final Assessment is performed, including the last measurement of f-VASI and T-VASI scores.

The study medication is discontinued and you receive instructions for any further follow‑up care.