96 Participants Needed

CIT-013 for HS

(Citylights Trial)

Recruiting at 23 trial locations
LM
Overseen ByLeonie M Middelink
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if CIT-013, an experimental treatment, can benefit individuals with Hidradenitis Suppurativa (HS), a skin condition that causes painful lumps. Researchers seek to assess whether CIT-013 can reduce HS activity and identify any side effects. Participants will receive either a high or medium dose of CIT-013 or a placebo every two weeks for 12 weeks. The trial seeks adults who have had HS for over six months, with painful lumps in at least two body areas, and who have not responded well to antibiotics. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop certain medications before starting. You must not have taken any systemic therapy for HS in the 28 days before the trial or any IV anti-infective therapy in the 14 days before the trial.

Is there any evidence suggesting that CIT-013 is likely to be safe for humans?

Research suggests that CIT-013 might be safe for humans. In earlier studies, participants tolerated CIT-013 well, and researchers found no major safety issues. CIT-013 reduces inflammation, which is linked to the immune system, and this method might cause fewer side effects than other treatments. However, because this trial is in an early stage, information on its safety remains limited. Volunteers in this trial can help researchers learn more about the safety of CIT-013 for treating hidradenitis suppurativa, a long-term skin condition.12345

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for hidradenitis suppurativa (HS), which often rely on antibiotics or anti-inflammatory medications, CIT-013 offers a novel approach. Researchers are excited about CIT-013 because it is administered through a series of subcutaneous injections, which might provide more targeted relief with potentially fewer side effects. Additionally, CIT-013 is being tested in varying doses, allowing researchers to fine-tune the treatment to maximize its effectiveness for different patients. This innovative approach could lead to a more personalized treatment option for those struggling with HS.

What evidence suggests that CIT-013 might be an effective treatment for HS?

Research has shown that CIT-013 could help treat conditions like Hidradenitis Suppurativa (HS) and rheumatoid arthritis. Earlier studies found CIT-013 to be effective and generally safe for patients. This treatment targets specific immune responses to reduce disease symptoms. The trial will evaluate different dosages of CIT-013, including high and medium doses, as well as a placebo. Similar treatments, such as remibrutinib, have helped many HS patients improve, with 72.7% showing better conditions. These findings suggest that CIT-013 might effectively reduce HS symptoms.13567

Who Is on the Research Team?

MK

Maarten Kraan

Principal Investigator

Citryll BV

Are You a Good Fit for This Trial?

Adults with Hidradenitis Suppurativa (HS) for over 6 months, having lesions in at least two areas and an abscess/nodule count of five or more. They must have tried antibiotics without success, had a recurrence after stopping them, be intolerant to them, or cannot take them due to other medical reasons.

Inclusion Criteria

I have fewer than 20 draining tunnels from my skin condition.
I have severe skin lesions in at least two different areas.
I have 5 or more abscesses or nodules.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks

12 weeks
6 visits (in-person, every 2 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CIT-013

Trial Overview

The trial is testing CIT-013 in high and medium doses against a placebo to see if it reduces HS symptoms. Participants will receive either the drug or placebo every two weeks for 12 weeks and attend bi-weekly clinic visits for monitoring.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: CIT-013 medium doseExperimental Treatment1 Intervention
Group II: CIT-013 high doseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Citryll BV

Lead Sponsor

Trials
1
Recruited
150+

Citations

NCT06993233 | A Study With CIT-013 in HS Patients

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.

Hidradenitis suppurativa: key insights into treatment success ...

In this trial, 72.7% of patients treated with remibrutinib achieved the simplified Hidradenitis Suppurativa Clinical Response score (HiSCR) (4).

Citryll presents positive data from phase I study of CIT-013 ...

Phase I trial data in rheumatoid arthritis patients demonstrates favorable safety, encouraging clinical activity, and robust biomarker ...

FIRST PATIENT DOSED IN CITRYLL'S PHASE IIA ...

Multi-center, randomized study designed to assess the efficacy, safety, and tolerability of CIT-013 in patients with hidradenitis suppurativa ...

Citryll doses first patient in Citylights trial for hidradenitis ...

CIT-013 reduces off-target effects and represents a potentially new therapeutic approach. Patients with HS experience pus-draining tunnels and ...

Hidradenitis Suppurativa | Innovation of Medicine

Learn how CIT-013 targets NETs to reduce inflammation and provide a new approach to treating hidradenitis suppurativa, a chronic inflammatory skin disease.

First Patient Dosed In Citryll's Phase IIA Hidradenitis ...

Multi-center, randomized study designed to assess the efficacy, safety, and tolerability of CIT-013 in patients with hidradenitis ...