CIT-013 for adults with hidradenitis suppurativa

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

This trial will try two doses of a drug called CIT-013 versus a placebo to see if it reduces disease activity in adults with hidradenitis suppurativa.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Citryll BV (Industry-sponsored)
• Locations: 24 sites (Barrie and 23 other locations)
• Trial ID: NCT06993233 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study compares two doses of CIT-013 (50 mg and 100 mg) to placebo given every other week for 12 weeks, with clinic visits and safety checks every two weeks. Eligible adults have HS for at least six months, lesions in two or more areas with at least one Hurley Stage II or III area, and an abscess and inflammatory nodule (AN) count of five or more. Participants must have had an inadequate response or intolerance to oral antibiotics and have fewer than 20 draining tunnels. The study measures changes in HS disease activity and monitors adverse events to characterize safety and tolerability.

Who should consider this trial

Good fit: Adults 18 or older with HS for more than six months, at least two affected anatomic areas (one Hurley II or III), an AN count ≥5, prior inadequate response or intolerance to oral antibiotics, and fewer than 20 draining tunnels are the intended participants.

Not a fit: Patients with mild HS, fewer than five abscesses/inflammatory nodules, those already able to use an effective approved therapy that is available and tolerated, or those with extensive draining tunnels (≥20) are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, CIT-013 could reduce inflammatory lesions and flares in adults with moderate-to-severe HS and improve symptoms and quality of life.

How similar studies have performed: Other biologic therapies such as adalimumab have shown benefit in HS, but CIT-013 is a novel investigational agent with limited prior clinical data in this condition.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

\- 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:

  1. Any other systemic therapy for HS (28 days before baseline)
  2. 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,

Where this trial is running

Barrie and 23 other locations

• Ca-01 — Barrie, Canada (Recruiting)
• Ca-05 — Calgary, Canada (Recruiting)
• Ca-02 — London, Canada (Recruiting)
• Ca-04 — Newmarket, Canada (Recruiting)
• Ca-03 — Winnipeg, Canada (Recruiting)
• De-06 — Bad Bentheim, Germany (Recruiting)
• De-01 — Bochum, Germany (Recruiting)
• De-04 — Dresden, Germany (Recruiting)
• De-02 — Frankfurt, Germany (Recruiting)
• De-08 — Kiel, Germany (Recruiting)
• De-03 — Oldenburg, Germany (Not_yet_recruiting)
• Erasmus UMC — Rotterdam, Netherlands (Recruiting)
• Pl-03 — Katowice, Poland (Recruiting)
• Pl-02 — Lodz, Poland (Not_yet_recruiting)
• Pl-01 — Rzeszów, Poland (Recruiting)
• Pl-05 — Wroclaw, Poland (Recruiting)
• Es-05 — Barcelona, Spain (Not_yet_recruiting)
• Es-04 — Madrid, Spain (Not_yet_recruiting)
• Es-02 — Santiago de Compostela, Spain (Not_yet_recruiting)
• Es-03 — Seville, Spain (Not_yet_recruiting)
• Es-01 — Valencia, Spain (Not_yet_recruiting)
• Gb-02 — Cardiff, United Kingdom (Not_yet_recruiting)
• Gb-05 — Chester, United Kingdom (Recruiting)
• Gb-04 — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Leonie M Middelink

Conditions Hidradenitis Suppurativa