Overview
Sponsor-declared trial summary
Acute allergic reaction
To evaluate the patient’s overall satisfaction with having access to Zeqmelit™ 6 mg in relation to the patient’s standard treatment overall, and in case of an acute allergic reaction.
Key facts
- Sponsor
- AcuCort AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 Jan 2024 → 24 Oct 2024
- Decision date (initial)
- 2023-06-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To evaluate the patient’s overall satisfaction with having access to Zeqmelit™ 6 mg in relation to the patient’s standard treatment overall, and in case of an acute allergic reaction.
Secondary objectives 2
- To evaluate the patient’s user experience of Zeqmelit™ 6 mg mouth film in case of an acute allergic reaction.
- To evaluate the patient’s perceived effectiveness of Zeqmelit™ 6 mg mouth film in case of an acute allergic reaction.
Conditions and MedDRA coding
Acute allergic reaction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10000656 | Acute allergic reaction | 10021428 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Study design This is a Phase IV, non-randomised, open-label, single-centre, low-interventional trial in patients with severe allergy.
|
2 | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Male or female patients ≥ 18 years of age, willing and able to give written informed consent for participating in the trial who previously have experienced acute allergic reactions and who is currently prescribed betamethasone tablets for treatment of such reactions.
Exclusion criteria 3
- Patient who cannot handle a web-based eDiary via their own electronic device (phone, tablet).
- Patients with other medical conditions that in the opinion of the Investigator would exclude the patient from trial participation.
- Patients who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall satisfaction in terms of general satisfaction and feeling safe. (Questions: 1f/4h, 2i, 3a-d, 4a-g).
Secondary endpoints 2
- User experience in terms of choice of treatment, having access to treatment and other medication. (Questions: 2a-g, 2j-n, 3e-g).
- Perceived effectiveness of Zeqmelit™ 6 mg mouth film. (Question: 2h).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Isicort 6 mg munsönderfallande film
PRD7885880 · Product
- Active substance
- Dexamethasone
- Substance synonyms
- DEXAMETASONE, DEXAMETHASONUM
- Pharmaceutical form
- ORODISPERSIBLE FILM
- Route of administration
- SPC
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 6 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 59788
- MA holder
- ACUCORT AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AcuCort AB
- Sponsor organisation
- AcuCort AB
- Address
- Scheeletorget 1, Lunds Allhelgonafors. Lunds Allhelgonafors.
- City
- Lund
- Postcode
- 223 63
- Country
- Sweden
Scientific contact point
- Organisation
- AcuCort AB
- Contact name
- James Kereki
Public contact point
- Organisation
- AcuCort AB
- Contact name
- James Kereki
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 50 | 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 |
|---|---|---|---|---|---|
| Sweden | 2024-01-26 | 2024-10-24 | 2024-01-26 | 2024-04-16 |
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 |
|---|---|---|---|
| ZEQ-001_Summary of Results SUM-80290
|
2025-04-25T08:03:29 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| ZEQ-001_Lay person Summary of Results | 2025-03-04T12:10:12 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | ZEQ-001_Layman Summary of Results | 1.0 |
| Summary of results (for publication) | ZEQ-001_Summary of Results-redacted | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-20 | Sweden | Acceptable 2023-06-14
|
2023-06-14 |