An efficacy and safety study of HRO350 in patients with mild-to-moderate psoriasis (the ‘HeROPA’ study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Arctic Bioscience AS

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

15 Mar 2023 → 7 Mar 2025

Decision date (initial)

2023-03-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Arctic Bioscience AS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety, Therapy

The primary objective is to evaluate the clinical efficacy of two oral doses of HRO350 (1050 mg and 2100 mg daily) compared to placebo in patients with mild-to-moderate psoriasis in order to select the recommended dose for phase 3.

Secondary objectives 1

1. The secondary objective is to evaluate the long-term safety of two oral doses of HRO350 (1 g and 2 g daily) in subjects with mild-to-moderate psoriasis.

Conditions and MedDRA coding

Psoriasis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Signed and dated informed consent
2. Males or females ≥18 years of age.
3. Diagnosis of chronic, active plaque psoriasis of mild to moderate severity which has been maintained without systemic treatment for at least 6 months prior to screening
4. Psoriasis Area and Severity Index (PASI) score ≥ 3≤ 10 at screening and baseline
5. Body Surface Area (BSA) ≥ 3 at screening and baseline
6. Static Physician’s Global Assessment (sPGA) ≥ 2 ≤ 4 at screening and baseline
7. Males, and females of child-bearing potential, must be willing to use highly effective methods of birth control during the study period and until 30 days after end of treatment. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intrauterine Devices (IUDs), sexual abstinence (if this is the preferred and usual lifestyle of the patient) or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for 12 months or more.

Exclusion criteria 7

1. Phototherapy [(i.e., ultraviolet radiation (UVB), psoralens and long-wave ultraviolet radiation (PUVA)] within 8 weeks of randomisation and during the trial
2. Any investigational drug administered within 4 weeks of randomisation or <5 times half-lives, whichever is the longer, and during the trial
3. Systemic anti-psoriatic treatment last 3 months (for biologics last 6 months) before randomisation and during the trial
4. Topical anti-psoriatic treatment last 2 weeks before randomisation
5. Any change in anti-inflammatory medication (for other chronic diseases than psoriasis) last 4 weeks before randomisation and during the trial
6. Any intake of omega-3 fatty acid supplements or medicines last 2 weeks before randomisation and during the trial
7. Known fish or vegetable oil (including soy) allergy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients with PASI50 (i.e., a ≥50% reduction in PASI score) from baseline to week 26

Secondary endpoints 10

1. Static PGA (sPGA)
2. BSA
3. sPGA × BSA product
4. Scalp PGA (ScPGA) Scale
5. Use of rescue medication
6. Dermatology Life Quality Index (DLQI)
7. SF-36
8. Safety endpoints include adverse events, biochemical and haematological lab tests, discontinuation rates.
9. Psoriasis Symptom Inventory (PSI)
10. Treatment Satisfaction Score (TSS)

Investigational products

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

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Arctic Bioscience AS

Sponsor organisation

Arctic Bioscience AS

Address

Industrivegen 42

City

Ørsta

Postcode

6155

Country

Norway

Scientific contact point

Organisation

Arctic Bioscience AS

Contact name

Clinical Trial Contact

Public contact point

Organisation

Arctic Bioscience AS

Contact name

Clinical Trial Contact

Third parties 2

Locations

4 EU/EEA countries · 49 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 25 files

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

Application history

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