CIT-013 for Hidradenitis suppurativa

Inclusion criteria

• {"criterion_text":"- The written ICF has been signed and dated by the participant prior to any trial-related activity\n- Participant’s body mass index is between 18 and 40 kg/m2 , inclusive\n- Male or female participants with HS of more than 6 months duration\n- ≥ 18 years of age at screening visit\n- Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III (according to Hurley classification system)\n- A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization\n- 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\n- Total draining tunnel count less than 20\n- 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\n- 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"}

Exclusion criteria

• {"criterion_text":"- Any current and/or recurrent clinically significant skin condition in the treatment area other than HS\n- 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)\n- History of malignancy with exception of non-melanoma skin cancer that has been excised and cured\n- Any known or suspicion for relevant infectious diseases associated with clinical signs (e.g., hepatitis B, or hepatitis C, or human immunodeficiency virus),\n- 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)\n- 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\n- Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening\n- Participant has a history of severe and/or multiple drug-allergies, or non-allergic drug reactions\n- 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)\n- 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\n- Any other multi-system autoimmune disease\n- 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)\n- 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\n- Pregnant or lactating or planning to get pregnant during the duration of the study\n- Participant has taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study\n- Dependency (as an employee or relative) to the sponsor or investigator\n- Prior treatment with biological and synthetic disease modifying drugs during the 6 weeks before baseline,"}

Primary endpoints

• {"endpoint_text":"- •\tProportion of participants with HiSCR75 in pooled dose groups of CIT 013 (50 mg CIT-013 and 100 mg CIT-013) versus placebo at V11 (D85)","definition_or_measurement_approach":"Proportion of participants achieving HiSCR75 measured at visit V11 (Day 85) comparing pooled CIT-013 dose groups (50 mg and 100 mg) versus placebo."}

Secondary endpoints

• {"endpoint_text":"- Incidence and severity of treatment-emergent (serious) adverse events ((S)AE)s\n- Change from baseline to Day 113 as measured by HiSCR50, HiSCR75 and HiSCR90 -\n- Change from baseline to Day 113 as measured by IHS4\n- Number of draining tunnels - change from baseline (V2) to all assessment timepoints (D29 [V5], D43 [V7], D85 [V11], D113 [V12])\n- Change in pain as reported by participant via numerical rating scale (NRS)\n- Change in Quality of Life as assessed by participant by the DLQI\n- Change in Quality of Life as assessed by participant by the Hidradenitis Suppurativa Quality of Life (HiSQoL)\n- Pharmacokinetic (PK) levels throughout the trial, per originally assigned treatment","definition_or_measurement_approach":"Incidence/severity of treatment-emergent (S)AEs collected throughout study; changes from baseline to Day 113 measured by HiSCR50/75/90 and by IHS4; draining tunnel counts compared from baseline (V2) to D29, D43, D85, D113; pain measured by participant NRS; QoL measured by DLQI and HiSQoL instruments; PK sampling throughout per assigned treatment arm."}

Methods

• Social media advertisements (Meta/Meta Ads) using country-language creatives (documents: K2_CITY LIGHTS_Meta Ads 1080x1080 Design and Social Media Wording in NL/DE/ES/PL). Targets: potential adult HS patients in each country (Netherlands, Germany, Spain, Poland).
• Landing page with country-specific wording (Landingpage_Wording files) to capture interest and pre-screen participants.
• Flyers and posters distributed in clinics and public spaces (Flyer_Wording and Poster_Wording files) with country-specific versions for NL/DE/ES/PL.
• Referral letters to clinicians for patient referral (Referral Letter documents).
• Pre-screening materials (Pre-Screening_Wording) to identify eligible participants prior to site contact.
• Link2Trials call scripts (K2_Link2Trials Call Script_Citylights files) for telephone recruitment and follow-up.
• Images advertisement master files for standardized visual adverts (Images Advertisement_Master_en and localized masters).
• Patient collaboration/partnership arrangements (e.g., Ipsory patient collaboration agreement in Spain) to support outreach.

Netherlands

Earliest CTIS Part Ii Submission Date

18-09-2025

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

208

Number Of Sites

1

Number Of Participants

5

Germany

Earliest CTIS Part Ii Submission Date

18-09-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

228

Number Of Sites

6

Number Of Participants

24

Spain

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

210

Number Of Sites

5

Number Of Participants

15

Poland

Earliest CTIS Part Ii Submission Date

10-09-2025

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

247

Number Of Sites

9

Number Of Participants

20

Primary sponsor

Full Name

Citryll B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands

Third parties

• {"country":"Sweden","full_name":"Offspring Biosciences","duties_or_roles":"4","organisation_type":"Industry"}
• {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Netherlands","full_name":"Ardena Bioanalysis B.V.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Clinfidence B.V.","duties_or_roles":"7,8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Symbio Clinical Research GmbH","duties_or_roles":"1,11,12,2,5,6","organisation_type":"Pharmaceutical company"}