Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Hidradenitis Suppurativa
The treatment effect will be assessed by reduction of HS activity, measured by the IHS4 score at the final follow-up 6 months post-baseline, as the difference between the IHS4 score at baseline (IHS40) and at the six-month follow-up (IHS46). Measurement IHS42 – IHS40= treatment effect. Justification for the use of IHS4…
Key facts
- Sponsor
- Gentofte Hospital, Frederiksberg Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 1 Apr 2025 → ongoing
- Decision date (initial)
- 2025-02-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The treatment effect will be assessed by reduction of HS activity, measured by the IHS4 score at the final follow-up 6 months post-baseline, as the difference between the IHS4 score at baseline (IHS40) and at the six-month follow-up (IHS46). Measurement IHS42 – IHS40= treatment effect.
Justification for the use of IHS4: “The IHS4 score is a recognized study scoring system for the treatment effect of HS treatment. It is routinely used for larger HS studies (21,29,30) “
1. The primary objective: IHS4 score:
Mild HS: ≤3 points
Moderate HS: 4-10 points
Severe HS: ≥11 points
Secondary objectives 1
- Assessed via questionnaires at baseline t=0 months, at the 3-month treatment t=3 months, and lastly at the three-month follow-up t=6 months. 1. Number of inflammatory nodules, non-inflammatory nodules, and draining tunnels. 2. Treatment satisfaction NRS is patient-reported from a scale NRS 0-10 0= not satisfied, 10= very satisfied. 3. HiSCR50 achieved or not achieved. 4. HiSQOL score 0-60. Each question is scored using an ordinal scale, ranging from 0-4. 0= no impact on the quality of life at all 4= extreme effect on the quality of life Some questions have a response option of ‘unable to do, due to HS’ that is scored 4. 5. Dermatology Life Quality Index (DLQI) score 0-30. 0-1 no effect at all on patient's life. 2- 5 small effect on patient's life. 6-10 moderate effect on patient's life. 11- 20 very large effect on patient's life. 21- 30 extremely large effect on patient's life. The MCID for DLQI is defined as a ≥4-unit decrease. 6. Pain: change in NRS score 0-10 at t=0 months, t=3 months and t= 6 months 0= no pain 10 = worst possible pain MCID for pain is considered to be ≥30% and ≥1 point reduction from baseline (maximum 10). 7. Suppuration: change in NRS score 0-10 at t=0 months, t=3 months and t= 6 months 0= no suppuration 10= constant suppuration 8. Pruritus (itch): change in NRS score 0-10 at t=0 months, t=3 months and t= 6 months 0= no itching 10= worst possible itch MCID for pruritis is considered to be ≥30% and ≥1 point reduction from baseline (maximum 10) 9. Patient reported disease severity NRS 0-10 0= no disease 10= worst imaginable disease 10. Would you recommend the procedure to other patients in your situation? (Yes/No)
Conditions and MedDRA coding
Hidradenitis Suppurativa
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Bilaterally affected areas on both sides of the body with the same degree of severity according to the Hurley stage • HS-patient at Gentofte Hospital • Signed informed consent before inclusion • Patient must have hidradenitis suppurativa diagnosis verified by a dermatologist • Patients must be cognitively intact enough to independently answer questions in the questionnaires • > 18 years old
Exclusion criteria 1
- • Myasthenia gravis • Eaton-Lamberts syndrom • Other neuromuscular disorders • Sensitivity/allergy over the ingredients • Pregnancy • Breastfeeding • Wish or plan to become pregnant • Emergency medical treatment for HS, such as intralesional triamcinolone injections in the treated areas • Emergency surgical treatment of HS in the treated areas • Comprised respiratory function • Patients taking one of following medications: aminoglycosides, anticholinergic drugs and muscle relaxants • Patient unable to give informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reduction in IHS4 score
Secondary endpoints 1
- 1. Reduction in number of inflammatory nodules, non-inflammatory nodules and draining tunnels. 2. High treatment satisfaction (NRS 0-10). 3. HiSCR50 achieved. 4. Reduction of HiSQOL. 5. DLQI reduction. 6. Pain reduction. 7. Suppuration reduction. 8. Pruritis reduction. 9. Reduction in patient reported disease severity. 10. If the patient would recommend the treatment to others
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
BOTOX, pulver til injektionsvæske, opløsning 100 Allergan-enheder
PRD9474853 · Product
- Active substance
- Botulinum Toxin Type A
- Substance synonyms
- Onaclostox, Botulinum toxin, type A, purified neurotoxin component, OnabotulinumtoxinA, BOTULINUM TOXIN A, BOTULIN TOXIN A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 400 U unit(s)
- Max total dose
- 400 U unit(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 31350
- MA holder
- ABBVIE A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
XEOMIN 100 units powder for solution for injection
PRD1975612 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 250 U unit(s)
- Max total dose
- 250 U unit(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- MA025/00701
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dysport, pulver til injektionsvæske, opløsning 300 enheder
PRD390760 · Product
- Active substance
- Botulinum Toxin Type a - Haemagglutinin Complex
- Substance synonyms
- AbobotulinumtoxinA, CNT52120, Clostridium botulinum A, strain Hall, neurotoxin heavy chain complex with hemagglutinin, and with neurotoxin, and with non-toxin non-hemagglutinin, CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTININ COMPLEX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1000 U unit(s)
- Max total dose
- 1000 U unit(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 46570
- MA holder
- INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid isotonisk "SAD", injektionsvæske, opløsning
PRD349415 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0 U unit(s)
- Max total dose
- 0 U unit(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 16404
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Gentofte Hospitalsvej 1
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Ditte Marie Saunte
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Ditte Marie Saunte
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Frederiksberg Hospital
- Sponsor organisation
- Frederiksberg Hospital
- Address
- Nordre Fasanvej 57, 1st Floor Entrance 2 1st Floor Entrance 2
- City
- Frederiksberg
- Postcode
- 2000
- Country
- Denmark
Scientific contact point
- Organisation
- Frederiksberg Hospital
- Contact name
- Ditte Marie Saunte
Public contact point
- Organisation
- Frederiksberg Hospital
- Contact name
- Ditte Marie Saunte
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Sponsor responsibilities
- Contact point sponsor
- Gentofte Hospital
- Article 77 implementation
- Gentofte Hospital
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-04-01 | 2025-05-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 1.1 |
| Protocol (for publication) | Questionnaires and patient reported outcomes | 1.1 |
| Protocol (for publication) | Summary of changes made according to RFI | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | Samtykkeerklring habile patienter | 1 |
| Subject information and informed consent form (for publication) | Subject information | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPc Dysport 300 units powder for solution for injection | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Summary of product characteristics | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Summary of product characteristics Botox | 1 |
| Synopsis of the protocol (for publication) | Synopsis of the protocol | 1.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-29 | Denmark | Acceptable 2025-02-25
|
2025-02-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-10 | Denmark | Acceptable 2025-02-25
|
2025-04-10 |