Proactive TDM versus standard use of biologics in psoriasis (HELIOS)

2023-509637-39-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 28 Nov 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 14 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 210
Countries 1
Sites 14

moderate-to-severe psoriasis

to assess if proactive TDM is non-inferior compared to standard of care with respect to sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 3-monthly study visits over a period of 18 months, in patients with moderate-to severe psoriasis treated with …

Key facts

Sponsor
Universitair Ziekenhuis Gent
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trial duration
28 Nov 2024 → ongoing
Decision date (initial)
2024-08-27
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
BELGIAN HEALTH CARE KNOWLEDGE CENTRE (“KCE”) · University Hospital Ghent

External identifiers

EU CT number
2023-509637-39-00
ClinicalTrials.gov
NCT06398106

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

to assess if proactive TDM is non-inferior compared to standard of care with respect to sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 3-monthly study visits over a period of 18 months, in patients with moderate-to severe psoriasis treated with novel biologics (secukinumab, ixekizumab or guselkumab).

Secondary objectives 6

  1. to compare proactive TDM to standard of care with respect to Disease activity
  2. to compare proactive TDM to standard of care with respect to Quality of life
  3. to compare proactive TDM to standard of care with respect to Treatment satisfaction
  4. to compare proactive TDM to standard of care with respect to Cost of treatment
  5. to compare proactive TDM to standard of care with respect to safety
  6. to identify baseline predictors for sustained disease control

Conditions and MedDRA coding

moderate-to-severe psoriasis

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Proactive TDM versus standard use of biologics in psoriasis (HELIOS)
a pragmatic, multicentric, randomised, controlled study
 Randomised Controlled None Intervention Group: Stepwise dose interval modifications based on drug levels (Proactive TDM)
Control Group: Standard clinical practice incl. empirical treatment modifactions.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. 1. Adults; aged 18 years or older
  2. 2. Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist
  3. 3. Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.
  4. 4. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures

Exclusion criteria 5

  1. 1. Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication)
  2. 2. Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc)
  3. Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline
  4. Presumed inability to follow the study protocol
  5. 5. Active pregnancy wish

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint is sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 3-monthly study visits over a period of 18 months.

Secondary endpoints 13

  1. ● Change from baseline at 18 months in PASI score. The PASI measures disease activity. The scores ranges from 0 (skin lesion free) to 72 with higher scores indicating higher disease activity.
  2. ● Change from baseline at 18 months in DLQI_R score. The DLQI_R measures QoL. The score ranges from 0 (no impact) to 30 (greatest impact) with higher scores indicating higher impact on quality of life.
  3. ● Change from baseline at 18 months in SF-36 score. The SF-36 measures QoL. The score ranges from 0 (maximum disability) to 100 (no disability). In the field of dermatology, the SF36 has been proposed as the instrument of choice for evaluating QoL in a generic way by Both et al.. Although we acknowledge that the SF36 can be perceived as more difficult to fill in by the patients, comparison of QoL measures by Fernandez-Penas et al, showed that SF‐36 was more sensitive than other instruments in d
  4. ● New onset or flare of arthritis
  5. ● Drug discontinuation (incl. reasons)
  6. ● Serious adverse events (SAE)
  7. ● Adverse events of special interest (AEoSI) ○ occurrence of infusion reactions ○ infections
  8. ● Cost of treatment (medication used and cost of TDM)
  9. ● Healthcare consumption (iMCQ)
  10. ● Number of dose modifications during the 18 months (0 – 6)
  11. ● Change from baseline at 18 months in TSQM score. The TSQM measures treatment satisfaction. TSQM is a 9-point questionnaire with scores ranging from 0 to 100. Higher scores indicate higher satisfaction.
  12. ● Change from baseline at 18 months in VAS score. The VAS measures treatment satisfaction. The VAS is a horizontal line of 100mm, with scores ranging from 0 (no satisfaction) to 10 (extreme satisfaction).
  13. ● iMCQ and EQ-5D-5L to measure cost-effectiveness. Shikiar et al. showed that the EQ-5D index score is generally more highly correlated with clinical endpoints, compared with the SF-36, but displayed about the same degree of responsiveness. The MCID for the EQ-5D score is considered 6 units.

Investigational products

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

Test 24

Taltz 80 mg solution for injection in pre-filled pen

PRD4144387 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/001
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Taltz 80 mg solution for injection in pre-filled pen

PRD4145804 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/001
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled syringe

PRD5602544 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled syringe

PRD5602543 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Taltz 80 mg solution for injection in pre-filled syringe

PRD4067518 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/004
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 300 mg solution for injection in pre-filled pen

PRD8526989 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/010
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 150 mg solution for injection in pre-filled pen

PRD4384729 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 300 mg solution for injection in pre-filled pen

PRD8526999 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/010
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Taltz 80 mg solution for injection in pre-filled syringe

PRD4144384 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/004
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Taltz 80 mg solution for injection in pre-filled syringe

PRD4145801 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/004
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 150 mg solution for injection in pre-filled pen

PRD4384703 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled pen.

PRD6533974 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Taltz 80 mg solution for injection in pre-filled pen

PRD4067521 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/001
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 150 mg solution for injection in pre-filled pen

PRD2398838 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled pen.

PRD6533971 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled syringe

PRD5602982 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled pen.

PRD6533972 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Taltz 80 mg solution for injection in pre-filled pen

PRD3995199 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/001
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 300 mg solution for injection in pre-filled pen

PRD8526997 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/010
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Taltz 80 mg solution for injection in pre-filled syringe

PRD3995196 · Product

Active substance
Ixekizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
80 mg milligram(s)
Max total dose
5760 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC13 — -
Marketing authorisation
EU/1/15/1085/004
MA holder
ELI LILLY AND COMPANY (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled syringe

PRD5602542 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 300 mg solution for injection in pre-filled pen

PRD8526998 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg/g milligram(s)/gram
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/010
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 150 mg solution for injection in pre-filled pen

PRD4384816 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
21600 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tremfya 100 mg solution for injection in pre-filled pen.

PRD6533973 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
L04AC16 — -
Marketing authorisation
EU/1/17/1234/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Ziekenhuis Gent

21 Total trials 11 Recruiting 6 Ended
Academic / Non-commercial
Sponsor organisation
Universitair Ziekenhuis Gent
Address
Corneel Heymanslaan 10
City
Gent
Postcode
9000
Country
Belgium

Scientific contact point

Organisation
Universitair Ziekenhuis Gent
Contact name
Rani Soenen

Public contact point

Organisation
Universitair Ziekenhuis Gent
Contact name
Rani Soenen

Locations

1 EU/EEA country · 14 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 210 14
Rest of world — 0 —

Investigational sites

Belgium

14 sites · Ongoing, recruiting
Centre hospitalier universitaire de Liege
Dermatology, Avenue De L'Hopital 1, 4000, Liege
Grand Hopital De Charleroi
Dermatologie, Rue De Villers 1, 6280, Gerpinnes
ASSOCIATIE DERMATOLOGIE Suys Erwin en Bonny Michiel FV
Dermatologie, Handelskaai 1 Bus G, 8500, Kortrijk
Az St-Jan Brugge-Oostende A.V.
Dermatologie, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Brussel
Dermatologie, Laarbeeklaan 101, 1090, Jette
Algemeen Ziekenhuis Alma
Dermatology, Ringlaan 15, 9900, Eeklo
Hopital Erasme
Dermatologie, Lennikse Baan 808, 1070, Anderlecht
UZ Leuven
Dermatologie, Herestraat 49, 3000, Leuven
Associatie dermatologie Maldegem
Dermatologie, Brugse Steenweg 181a, 9990, Maldegem
Universitair Ziekenhuis Gent
Dermatologie, Corneel Heymanslaan 10, 9000, Gent
Az Maria Middelares Gent
Dermatologie, Buitenring-Sint-Denijs 30, 9000, Gent
CHU Saint Pierre
Dermatology, Waterloolaan 129, 1000, Brussels
Dermatologiepraktijk Huidziekten Geel
Dermatologie, Laarsveld 21, 2440, Geel
Cliniques Universitaires Saint-Luc
Dermatologie, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2024-11-28 2024-12-23

Results and documents

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

Documents 29 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-509637-39-00_public 1.5
Protocol (for publication) D4_Patient facing documents_questionnaire_DLQI - FR 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_DLQI - NL 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_EQ-5D-5L - FR 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_EQ-5D-5L - NL 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_iMCQ - FR 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_iMCQ - NL 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_SF-36 - FR 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_SF-36 - NL 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_TSQM - FR 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_TSQM - NL 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_VAS - FR 1.1
Protocol (for publication) D4_Patient facing documents_questionnaire_VAS - NL 1.1
Protocol (for publication) D5_Assessments_IGA - FR 1.1
Protocol (for publication) D5_Assessments_IGA - NL 1.1
Protocol (for publication) D5_Assessments_PASI and BSA - FR 1.1
Protocol (for publication) D5_Assessments_PASI and BSA - NL 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF DUTCH_public 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF FR_public 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF sponsor statement_public 1.0
Subject information and informed consent form (for publication) L2_Other subject information material Website content_public 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cosentyx - secukinumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Taltz - ixekizumab 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Tremfya - guselkumab 1
Synopsis of the protocol (for publication) D1_Protocol synopsis DUTCH 1.5
Synopsis of the protocol (for publication) D1_Protocol synopsis ENG 1.5
Synopsis of the protocol (for publication) D1_Protocol synopsis FR 1.5
Synopsis of the protocol (for publication) D1_Protocol synopsis GERMAN 1.5

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-12 Belgium Acceptable
2024-08-27
 2024-08-27
2 SUBSTANTIAL MODIFICATION SM-1 2024-09-26 Belgium Acceptable 2024-10-29
3 NON SUBSTANTIAL MODIFICATION NSM-1 2024-11-05 Belgium Acceptable 2024-11-05
4 NON SUBSTANTIAL MODIFICATION NSM-2 2024-12-19 Belgium Acceptable 2024-12-19
5 SUBSTANTIAL MODIFICATION SM-2 2025-01-15 Belgium Acceptable 2025-02-14
6 NON SUBSTANTIAL MODIFICATION NSM-3 2025-03-12 Belgium Acceptable 2025-03-12
7 SUBSTANTIAL MODIFICATION SM-3 2025-05-20 Belgium Acceptable 2025-06-19
8 NON SUBSTANTIAL MODIFICATION NSM-4 2026-01-08 Belgium Acceptable 2026-01-08
9 SUBSTANTIAL MODIFICATION SM-4 2026-01-09 Belgium Acceptable 2026-02-27