Phase 2, randomized, double-blind, placebo-controlled study of IC0624 as first-line therapy in patients with active mild to moderate Hidradenitis Suppurativa (HS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ichthyol-Gesellschaft Cordes Hermanni & Co. GmbH & Co. KG

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

3 Mar 2025 → 8 Jan 2026

Decision date (initial)

2025-02-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To evaluate the clinical efficacy of a 6-week intake of IC0624

Secondary objectives 4

1. To evaluate the clinical efficacy of IC0624 in comparison with placebo at all timepoints.
2. To evaluate pain sensation during intake of IC0624 in comparison with placebo at all timepoints.
3. To evaluate the safety and tolerability profile of IC0624 in comparison with placebo at all timepoints.
4. To evaluate the influence of IC0624 on the subjects’ quality of life (QoL) and treatment satisfaction.

Conditions and MedDRA coding

Hidradenitis Suppurativa

Regulatory references

Scientific advice from competent authorities

Ichthyol-Gesellschaft Cordes Hermanni & Co. GmbH & Co. KG

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Written informed consent prior to any study-related measure.
2. Male, female, diverse subjects aged 18 to 65 years.
3. Skin type Fitzpatrick I-VI
4. Clinically confirmed diagnosis of mild to moderate Hidradenitis Suppurativa (HS)
5. IHS4 of a minimum of 1 (corresponding to the existence of one node) and a maximum of 10 with nodes and abscesses being predominantly located in inguinal, axillar, and gluteal area.
6. Hurley Stage I to II
7. Expected high patient compliance in administering the study medication and following the study instructions including diary documentation.

Exclusion criteria 18

1. Severe Hidradenitis Suppurativa (HS)
2. Patients participating in another clinical study (medical devices, or medicinal products) during the 4 weeks before inclusion into this clinical trial and during the course of this clinical trial
3. Systemic treatment with clindamycin, rifampicin, doxycycline, minocycline, or erythromycin for any reason within the 4 weeks preceding Visit 1
4. Axillary, inguinal or anogenital treatment with topical antibiotics within the 4 weeks preceding Visit 1
5. Treatment with Janus kinase (JAK) inhibitors or HS specific antibodies within 12 weeks preceding Visit 1
6. Any previous randomization into this clinical trial
7. Any suspicion of current drug or alcohol abuse
8. Institutionalization because of legal or regulatory order
9. Dependency (as an employee or relative) to the sponsor/responsible CRO or investigator or members of the investigational team
10. IHS4 of 11 or higher
11. Diagnosis of acne conglobata
12. Hypersensitivity to sulfonated shale oils, such as ammonium and/or sodium bituminosulfonate and/or any of the investigational product’s excipients
13. Rare hereditary galactose or fructose intolerance, lactase deficiency, saccharase-isomaltase deficiency or glucose-galactose malabsorption
14. Current treatment with tetracyclines
15. Evidence of any clinically significant or unstable medical condition, that in the view of the investigator would jeopardize patient´s safety in the setting of the clinical trial.
16. Subjects of childbearing potential not using or not willing to use a highly effective method of contraception (failure rate of less than 1% per year) during the clinical trial
17. Pregnant or breast-feeding patients
18. Hurley stage III

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint will be the HiSCR50 at week 6.

Secondary endpoints 4

1. Secondary efficacy endpoints: HiSCR50 at weeks 2 and 4; HiSCR75 at weeks 2, 4 and 6; AN (Abscesses and Inflammatory Nodules) count at weeks 2, 4 and 6; IHS4 at weeks 2, 4 and 6; Inflammation marker hsCRP at week 6 in comparison with baseline measurement at week 0
2. Secondary pain endpoint: Maximum daily pain sensation based on diary documentation within preceding 24 hours; Intake of pain medication for HS
3. Secondary safety and tolerability endpoints: (Serious) Adverse Events; Laboratory analysis at week 6 in comparison with analysis at week 0 (baseline) for liver transaminases (GGT, GOT/AST, GPT/ALT), creatinine, CK, HDL and LDL cholesterol, differential blood count.
4. Secondary QoL endpoints: DLQI at week 6 in comparison with week 0 (past 7 days assessment); WHO-5 at week 6 in comparison with baseline at week 0; Indication of subjective satisfaction with the study treatment based on verbally asked questions at week 6

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ichthyol-Gesellschaft Cordes Hermanni & Co. GmbH & Co. KG

Sponsor organisation

Ichthyol-Gesellschaft Cordes Hermanni & Co. GmbH & Co. KG

Address

Sportallee 85, Gross Borstel Gross Borstel

City

Hamburg

Postcode

22335

Country

Germany

Scientific contact point

Organisation

Ichthyol-Gesellschaft Cordes Hermanni & Co. GmbH & Co. KG

Contact name

Dr. Annette Sethmann

Public contact point

Organisation

Ichthyol-Gesellschaft Cordes Hermanni & Co. GmbH & Co. KG

Contact name

Dr. Annette Sethmann

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications