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Evaluation of CIT-013 at two dose levels compared to placebo for treating moderate to severe Hidradenitis Suppurativa

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on Hidradenitis Suppurativa (HS), a chronic skin condition that causes painful bumps and abscesses in areas where skin rubs together. The study will test a new medication called CIT-013, which will be given through subcutaneous injection (an injection under the skin) to patients with moderate to severe forms of the disease.

The study will compare two different doses of CIT-013 (50 mg and 100 mg) against a placebo to determine how well the medication works in treating the symptoms of Hidradenitis Suppurativa. The purpose is to evaluate if CIT-013 can effectively reduce disease activity in people with this condition.

During the study, participants will receive multiple doses of either CIT-013 or placebo over several weeks. The treatment will be administered as a concentrate that is prepared as a solution for injection. The study will monitor various aspects of the disease, including changes in the number of skin lesions, pain levels, and overall quality of life for the participants.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial trial visit
You will be assigned randomly to one of three groups: 50 mg CIT-013, 100 mg CIT-013, or placebo (salt water solution)
The assignment is done by chance, and neither you nor the medical staff will know which group you are in
Step 2
Treatment period
You will receive subcutaneous injections (injections under the skin) of the assigned treatment
The treatment continues through multiple visits over approximately 85 days
Your Hidradenitis Suppurativa (a skin condition with painful bumps) will be monitored regularly
The medical staff will count the number of active bumps and tunnels in affected areas
You will be asked to rate your pain level using a number scale
You will complete quality of life questionnaires about how the condition affects your daily life
Step 3
Follow-up period
After the treatment period ends, you will continue to be monitored until day 113
The medical staff will check for any changes in your condition
Blood samples will be taken to measure the amount of medication in your system
Any side effects will be recorded and monitored
Step 4
Final assessment
The final evaluation will occur on day 113
The medical staff will perform a final count of active bumps and tunnels
You will complete final quality of life assessments
Any ongoing side effects will be documented

Who can join the trial?

17 criteria

Must sign and date a written Informed Consent Form (ICF) before starting any trial activities
Body Mass Index (BMI) must be between 18 and 40 kg/m² (BMI is a measure of body fat based on height and weight)
Must have had Hidradenitis Suppurativa for more than 6 months
Must be 18 years or older when screened for the study
Must have skin lesions in at least 2 different body areas, with one area being moderate to severe (classified as Hurley Stage II or III)
Must have at least 5 abscesses and inflammatory nodules during screening and on Day 1
check
Must have either:
- Not responded well to oral antibiotics, or
- Had condition return after stopping antibiotics, or
- Been unable to tolerate antibiotics, or
- Have a medical reason preventing use of oral antibiotics
- Must have fewer than 20 draining tunnels (channels under the skin)
- check
  Women who can become pregnant must:
  - Use highly effective birth control (with less than 1% failure rate per year)
  - Continue birth control during the trial and for 5 weeks after the last dose
  - Have a negative pregnancy test before starting the trial
  - Men who can father children must:
    
    Use condoms during the trial and for 5 weeks after the last dose
    Inform female partners about using highly effective birth control
    Not donate sperm during this period

Who cannot join the trial?

14 criteria

Active or chronic bacterial, viral, or fungal infections requiring treatment
History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
Significant heart problems including heart failure or unstable heart disease
Current diagnosis of tuberculosis or positive TB test
Presence of other severe skin conditions that could interfere with evaluating the study treatment
Liver disease or abnormal liver function tests
Pregnant or breastfeeding women
Use of other investigational drugs within 30 days before starting the study
History of substance abuse in the past 12 months
Major surgery planned during the study period
Severe kidney disease requiring dialysis
Known allergic reactions to similar medications
Mental health conditions that could affect participation in the study
Use of medications that could interact with the study drug

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

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Investigated drugs

CIT-013 is an investigational medication being studied for the treatment of Hidradenitis Suppurativa (HS), a chronic inflammatory skin condition. This medication is being tested to see if it can help reduce the severity of symptoms and disease activity in people with moderate to severe HS. The trial is examining two different dose levels of the medication to determine which might be most effective in treating the condition.

What is already known about the treatment

CIT-013 - An investigational medication currently being studied in Phase 2a clinical trials for the treatment of Hidradenitis Suppurativa (HS), a chronic inflammatory skin condition. The drug is being evaluated at two different dose levels to assess its effectiveness in patients with moderate to severe forms of the disease. While the specific mechanism of action and route of administration are not publicly disclosed in the available trial data, this experimental treatment is being tested in a placebo-controlled setting to determine its potential therapeutic benefits for reducing disease activity in HS patients. The study represents an important step in developing new treatment options for this challenging skin condition.

Investigated diseases

Hidradenitis Suppurativa - A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. The condition begins with tender areas of skin that develop into swollen bumps, which may break open and leak fluid. Over time, these areas can develop into tunnels under the skin connecting different sites of inflammation. The condition tends to be long-lasting and can worsen over time, with new lumps developing as others heal. It often appears after puberty and can be influenced by hormonal changes.