#1 Clinical Trials Search in Europe

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

2 1

What is this study about?

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.

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

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

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

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 Study?

  • 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
  • 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)
  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Technische Universitaet Dresden Dresden Germany
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland

Other Sites

Site Name City Country Status
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Med Polonia Sp. z o.o. Poznan Poland
Specderm Poznanska Sp. j. Bialystok Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Amicare Sp. z o.o. S.K. Lodz Poland
Medizinisches Versorgungszentrum DermaKiel GmbH Kiel Germany
Hospital Provincial De Conxo Santiago De Compostela Spain
St. Josef-Hospital Bochum Germany
Etkdykc Ufhswmokywdn Matsizr Covgyhu Rgfpasrdj (hcjdxpe Mys Rotterdam The Netherlands
Geolhn Ugphqftdpl Fktqujywx Frankfurt Germany
Pksyuth Shz z oxzi Katowice Poland
Hvfrjqzy Dt Lm Sirup Cujn I Skfq Pwr Barcelona Spain
Cuwotiq Benkc Kamxadvlwlz Pcaimcyf Sjc z owpr Gdansk Poland
Twluowvsjis ugp Snixiwiszvr Bistfagb Gwgo Bad Bentheim Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
29.09.2025
Poland Poland
Recruiting
29.09.2025
Spain Spain
Recruiting
29.09.2025
The Netherlands The Netherlands
Recruiting
29.09.2025

Trial locations

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.

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.

Trial ID:
2025-521684-12-00
Protocol code:
CITRYLL003
NCT ID:
NCT06993233
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study to evaluate the effectiveness and safety of LAD328 in adults with moderate to severe hidradenitis suppurativa

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Poland Spain

  • A study to evaluate the effectiveness and safety of BFB759 in adults with moderate to severe hidradenitis suppurativa

    Recruiting

    2 1
    Bulgaria Czechia Germany Poland Spain