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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 (HS)
EU CTIS ID: 2025-521684-12-00
What this study is testing
To evaluate the efficacy of CIT-013 in participants with moderate to severe HS
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The written ICF has been signed and dated by the participant prior to any trial-related activity
- Participant’s body mass index is between 18 and 40 kg/m2 , inclusive
- 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
You likely can't join if
- Any current and/or recurrent clinically significant skin condition in the treatment area other than HS
- Prior treatment with any of the following medications before baseline: a. Any other systemic therapy for HS (28 days before baseline) b. 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
- Any known or suspicion for relevant infectious diseases associated with clinical signs (e.g., hepatitis B, or hepatitis C, or human immunodeficiency virus),
- Evidence of active tuberculosis (TB) or being at high risk for TB (excluded by negative blood test at screening and - if prescribed by local law - by imaging via X-ray of the thorax which can be taken within 3 months before screening)
- History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis
See the full eligibility criteria
Who can join
- The written ICF has been signed and dated by the participant prior to any trial-related activity
- Participant’s body mass index is between 18 and 40 kg/m2 , inclusive
- 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
- Women of childbearing potential (WOCBP)1 must agree to use a highly effective method of birth control, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly 2, during the trial and 5 weeks after the last dose, and must have a negative serum pregnancy test prior to entry into the trial
- Fertile males with partners who are WOCBP must agree to use a condom and inform their WOCBP partner that highly effective methods of birth control are recommended to avoid pregnancy, applying for the time period during the trial and 5 weeks after the last dose. Male participants in general must agree to refrain from donating sperm
What rules you out
- Any current and/or recurrent clinically significant skin condition in the treatment area other than HS
- Prior treatment with any of the following medications before baseline: a. Any other systemic therapy for HS (28 days before baseline) b. 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
- Any known or suspicion for relevant infectious diseases associated with clinical signs (e.g., hepatitis B, or hepatitis C, or human immunodeficiency virus),
- Evidence of active tuberculosis (TB) or being at high risk for TB (excluded by negative blood test at screening and - if prescribed by local law - by imaging via X-ray of the thorax which can be taken within 3 months before screening)
- History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis
- Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening
- Participant has a history of severe and/or multiple drug-allergies, or non-allergic drug reactions
- 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)
- Participant has a known hypersensitivity to any of the inactive ingredients (L-histidine, Histidine-HCl monohydrate, Sucrose, Polysorbate) of the study treatment, or to drugs of similar chemical structure or pharmacological profile
- Any other multi-system autoimmune disease
- Significant clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)
- Participant has any other condition which, in the investigator’s opinion will interfere with trial participation or will affect the safety, efficacy or measurements during the study
- Pregnant or lactating or planning to get pregnant during the duration of the study
- Participant has taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study
- Dependency (as an employee or relative) to the sponsor or investigator
- Prior treatment with biological and synthetic disease modifying drugs during the 6 weeks before baseline,
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom. 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 EU CTIS; the study team decides eligibility.