A study to test long-term treatment with spesolimab in people with a skin condition disease called hidradenitis suppurativa (HS) who took part in a previous study with spesolimab

JRCT ID: jRCT2031240075

Registered date:10/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hidradenitis suppurativa
• Date of first enrollment: 04/07/2024
• Target sample size: 550
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Lithuania,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Norway,Japan,Philippines,Japan,Poland,Japan,Portugal,Japan,Singapore,Japan,Slovakia,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): Drug: Spesolimab (Spevigo) / Solution for injection

Outcome(s)

• Primary Outcome: The primary endpoint is the occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including REP (i.e., 16 weeks after the last study treatment).
• Secondary Outcome: Not applicable.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
3. Participants who have completed treatment in the parent HS spesolimab trial without premature discontinuation and are willing and able to continue treatment in this trial. etc.

Exclude criteria

1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
2. Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
3. Participants who require/ intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial. etc.

Related Information

• Primary Sponsor: Arita Takafumi
• Secondary ID(s): NCT06241573