Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
27
Countries
1
Sites
1
Atopic dermatitis (Eczema)
To assess safety and local tolerability of DLQ03 in patients with atopic dermatitis
Key facts
- Sponsor
- Dermaliq Therapeutics Inc.
- 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
- 4 Aug 2022 → 21 Nov 2023
- Decision date (initial)
- 2022-06-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Dermaliq Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic
To assess safety and local tolerability of DLQ03 in patients with atopic dermatitis
Conditions and MedDRA coding
Atopic dermatitis (Eczema)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age, inclusive. The health status is verified by absence of evidence of any clinically significant active or uncontrolled chronic disease other than AD that potentially may influence the adherence to the study and/or assessments in the study, following a detailed medical history and a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology, and urinalysis.
- Diagnosed with AD according to the Hannifin criteria (Hannifin 1980
- Suitable target lesion defined as an eczema lesion of at least 0.5% BSA (excluding the face) at screening and baseline day 1 for part A and 2 suitable target lesions defined as two eczema lesions of at least 0.5% BSA (excluding the face) at screening and baseline day 1 for part B.
- Target lesion is cultured positive for S. aureus on two consecutive occasions during the screening period:
Exclusion criteria 2
- Any current and / or recurrent clinically significant skin condition which will interfere with the clinical findings of the study as assessed by the investigator.
- Ongoing use of prohibited atopic dermatitis treatments. Washout periods prior to baseline (first dose of the study drug) are as follows:
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit
- Concomitant medication throughout the study at every study visit
- Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule
- Clinical laboratory tests (Hematology, blood chemistry and urinalysis) as per assessment schedule
- ECG parameters (Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF) as per assessment schedule
- Local irritation grading scale
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB14239MIG · Substance
- Active substance
- Iodine
- Pharmaceutical form
- TOPICAL USE
- Route of administration
- TOPICAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 21 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Iodine is manufactured at the strengths: 0.02% w/v and 0.1% w/v
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dermaliq Therapeutics Inc.
- Sponsor organisation
- Dermaliq Therapeutics Inc.
- Address
- 1201 North Market Street Suite 111
- City
- Wilmington
- Postcode
- 19801-1156
- Country
- United States
Scientific contact point
- Organisation
- Dermaliq Therapeutics Inc.
- Contact name
- E. (Elisabeth) Rowold
Public contact point
- Organisation
- Dermaliq Therapeutics Inc.
- Contact name
- E. (Elisabeth) Rowold
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 27 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre For Human Drug Research
NA, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-08-04 | 2023-11-21 | 2022-08-16 | 2023-10-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-57884
|
2024-11-18T13:39:40 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results for Laypersons | 2024-11-18T13:40:48 | Submitted | Laypersons Summary of Results |
| Summary of Results for Laypersons | 2024-11-18T13:41:37 | Submitted | Laypersons Summary of Results |
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Summary of Results for Laypersons | 1 |
| Laypersons summary of results (for publication) | Summary of Results for Laypersons | 1 |
| Summary of results (for publication) | Summary of Results | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-02 | Netherlands | Acceptable with conditions 2022-06-03
|
2022-06-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2022-08-12 | Netherlands | Acceptable with conditions 2022-06-03
|
2022-08-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-12-14 | Netherlands | Acceptable 2022-12-23
|
2022-12-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-07-26 | Netherlands | Acceptable 2022-12-23
|
2023-07-26 |