A Study With CIT-013 in HS Patients

Официальное название

A Phase 2a Double Blind, Randomized, Parallel Arm, Placebo-controlled Trial to Investigate the Effects of Two Dose Levels of CIT-013 on Disease Activity in Patients With Hidradenitis Suppurativa

Обзор

The goal of this clinical trial is to learn if CIT-013 works to treat Hidradenitis Suppurativa in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: Does CIT-013 lower the disease activity of HS patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of HS. Participants will: Take receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period

Вмешательства

• Препарат CIT-013 high dose
  subcutaneous injection
• Препарат CIT-013 medium dose
  subcutaneous injection
• Препарат Placebo
  subcutaneous injection

Первичные конечные точки

• Proportion of participants with HiSCR75 on CIT 013 versus placebo [Срок оценки: week 12]

Вторичные конечные точки (2)

• Incidence of TEAEs as assessed by CTCAE [Срок оценки: week 12]
• Maximum Plasma Concentration of CIT-013 before doses [Срок оценки: 4, 6, 10 and 12 weeks]

Критерии участия

Критерии включения

• Male or female participants with HS of more than 6 months duration,
• 18 years of age at screening visit,
• Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III (according to Hurley classification system),
• A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization,
• Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS,
• Total draining tunnel count less than 20

Критерии исключения

\- Participants for whom an approved therapy with demonstrated clinical benefit is indicated, available and expected to be tolerated, OR choose to proceed with standard of care treatment options over the IP (after being appropriately informed of the treatment options, risks, and benefits).

Any current and/or recurrent clinically significant skin condition in the treatment area other than HS,

• Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline
• Prior treatment with any of the following medications before baseline:

• Any other systemic therapy for HS (28 days before baseline)
• Any IV anti-infective therapy (14 days before baseline)
• History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 8 центров

• PL-06 — Bialystok
• PL-08 — Gdansk
• PL-03 — Katowice
• PL-02 — Lodz
• PL-10 — Lodz
• PL-09 — Poznan
• PL-01 — Rzeszów
• PL-05 — Wroclaw

Германия · 6 центров

• DE-06 — Bad Bentheim
• DE-01 — Bochum
• DE-04 — Dresden
• DE-02 — Frankfurt
• DE-08 — Kiel
• DE-03 — Oldenburg

Канада · 5 центров

• CA-01 — Barrie
• CA-05 — Calgary
• CA-02 — London
• CA-04 — Newmarket
• CA-03 — Winnipeg

Испания · 5 центров

• ES-05 — Barcelona
• ES-04 — Madrid
• ES-02 — Santiago de Compostela
• ES-03 — Seville
• ES-01 — Valencia

Великобритания · 3 центра

• GB-02 — Cardiff
• GB-05 — Chester
• GB-04 — London

Нидерланды · 1 центр

• Erasmus UMC — Rotterdam

Идентификаторы

NCT: NCT06993233 · CITRYLL003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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