A study to test whether spesolimab helps people with a skin disease called hidradenitis suppurativa

JRCT ID: jRCT2041230016

Registered date:30/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hidradenitis suppurativa
• Date of first enrollment: 08/05/2023
• Target sample size: 460
• 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 infusion
Drug: Spesolimab (Spevigo) / Solution for injection
Drug: Placebo / Solution for infusion
Drug: Placebo / Solution for injection

Outcome(s)

Primary Outcome

Part 1:
Percent change from baseline in Draining fistula/tunnel (dT) count at Week 8

Secondary Outcome

Part 1:
Percent change from baseline in dT count at Week 16
Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value at Week 8
Absolute change from baseline in IHS4 value at Week 16
Occurrence of treatment emergent adverse events (TEAEs)

Key inclusion & exclusion criteria

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

Include criteria

1. Of full age of consent at screening.
2. Signed and dated written informed consent in accordance with International Council on Harmonisation Good clinical practice (ICH GCP) and local legislation prior to admission to the trial.
3. Moderate to severe HS.
4. HS lesions in at least 2 distinct anatomic areas.
5. Biologic naive or Tumor Necrosis Factor inhibitor (TNFi) exposed for HS.
6. For biologic naive, inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS.
7. Total AN count of greater than or equal to 5.
8. Total dT count of at least 1 at Baseline visit.

Exclude criteria

1. Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
2. Prior exposure to any immunosuppressive biologic other than TNFi for HS.
3. Prior exposure to Interleukin 36 receptor (IL-36R) inhibitors including spesolimab.
4. Treated with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer.
5. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
6. Participants with history of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
7. Participants with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening) or who has ever received stem cell therapy (e.g., Remestemcel-L).
8. Participants with any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.

Related Information

• Primary Sponsor: Arita Takafumi
• Secondary ID(s): NCT05819398