BridgeMD
New treatment option for Hidradenitis Suppurativa (HS)
Official title A Study With CIT-013 in HS Patients
ClinicalTrials.gov ID: NCT06993233
What this study is testing
What is CIT-013 high dose?
CIT-013 high dose is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hidradenitis suppurativa (hs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- \- Participants for whom an approved therapy with demonstrated clinical benefit is indicated, available and expected to be tolerated, OR choose to...
- 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,
See the full eligibility 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...
- Total draining tunnel count less than 20
- \- 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...
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Barrie, Canada
- Calgary, Canada
- London, Canada
- Newmarket, Canada
- Winnipeg, Canada
- Bad Bentheim, Germany
- Bochum, Germany
- Dresden, Germany
- Frankfurt, Germany
- Kiel, Germany
- Oldenburg, Germany
- Rotterdam, Netherlands
- Bialystok, Poland
- Gdansk, Poland
- Katowice, Poland
- Lodz, Poland
- Poznan, Poland
- Rzeszów, Poland
- Wroclaw, Poland
- Barcelona, Spain
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barrie, Canada; Calgary, Canada; London, Canada; Newmarket, Canada; Winnipeg, Canada; Bad Bentheim, Germany and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.