Clinical Trials Register

Summary
EudraCT Number:	2021-000049-42
Sponsor's Protocol Code Number:	UNI50007-201
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-02-03
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2021-000049-42

A.3

Full title of the trial

Orismilast for the treatment of mild to severe hidradenitis suppurativa; A phase 2, open-label, proof of concept trial comparing the response to an oral tablet formulation of orismilast in adult patients with mild, moderate, and severe hidradenitis suppurativa; A single-centre, prospective, single arm, investigator-initiated clinical trial with 16 weeks twice times daily oral treatment, with extension of total treatment duration to 52 weeks for responders

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A proof of concept trial to assess the efficacy and safety of orismilast in adult patients with mild, moderate, and severe hidradenitis suppurativa;

A.3.2

Name or abbreviated title of the trial where available

OSIRIS

A.4.1

Sponsor's protocol code number

UNI50007-201

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Zealand University Hospital (Universitetshospital Sjælland)
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Union Therapeutics A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Zealand University Hospital (Universitetshospital Sjælland)
B.5.2	Functional name of contact point	Prof. Gregor Jemec
B.5.3	Address:
B.5.3.1	Street Address	Sygehusvej 10
B.5.3.2	Town/ city	Roskilde
B.5.3.3	Post code	4000
B.5.3.4	Country	Denmark
B.5.6	E-mail	gbj@regionsjaelland.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Orismilast
D.3.2	Product code	previously LEO32731
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Orismilast
D.3.9.1	CAS number	1353546-86-7
D.3.9.2	Current sponsor code	LEO 32731
D.3.9.3	Other descriptive name	Orismilast
D.3.9.4	EV Substance Code	SUB204073
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10 to 30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hidradenitis suppurativa

E.1.1.1

Medical condition in easily understood language

Hidradenitis suppurativa

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10020041
E.1.2	Term	Hidradenitis suppurativa
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Explore evidence of efficacy of orismilast in the oral treatment of patients with HS when applied twice daily for up to 16 weeks

E.2.2

Secondary objectives of the trial

The secondary objective is to add depth and detail to the primary endpoint through the use of validated scores and patient reported out-come measures

An exploratory objective is to assess the long-term efficacy, safety and tolerability of orismilast in the oral treatment of patients who responded after the initial 16 week of treatment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female adult patients, 18 years of age or older.
2. Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
3. Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
4. Has a total inflammatory lesions (AN) count of greater than or equal to 2.
5. Total draining fistula count of less than or equal to 30.
6. A stable analgesic dose for 2 weeks prior to baseline

E.4

Principal exclusion criteria

1. Presence of active skin lesions other than HS that could interfere with the assessment of HS.
2. Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
3. Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
4. Any oral antibiotic within 28 days prior to baseline visit.
5. Receipt of a live vaccine within 14 days prior to screening.
6. Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
7. Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating.

9. Active systemic infection and/or fever – or clinical signs of local infection (stinging, increased soreness, burning sensation, erythematous perilesional halo or other signs of infection) - during the last 2 weeks prior to first drug administration.
10. History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
11. Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Remestemcel-L).
12. Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
13. Relevant chronic or acute infections (exception: common cold), as determined by the investigator, including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
a. In case of a positive hepatitis C antibody test, a positive reflex testing for Hepatitis C RNA PCR is considered positive.
14. Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug administration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation).
15. Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, and >2-fold ULN elevation in alkaline phosphatase.
16. Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than HS, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would compromise the safety of the patient or compromise the quality of the data, make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial.
17. Planned use of laser or other hair removal procedures over HS-affected areas during the trial period.
18. Planned HS surgery during the trial period.

E.5 End points

E.5.1

Primary end point(s)

Percent change from Baseline in AN (abscesses and nodules) count at Week 16.

E.5.1.1

Timepoint(s) of evaluation of this end point

week 2, 4, 12, 16

E.5.2

Secondary end point(s)

Change from Baseline in abscess, nodule, and draining fistula counts at Week 16.
• Change from Baseline in IHS4 value at Week 16.
• Change from Baseline in Patient’s Global Assessment of Skin Pain (NRS) at Week 16.
• Change from Baseline in HiSQOL Total Score at Week 16.

• Occurrence of treatment emergent adverse events (AEs).
• Change in clinical laboratory parameters (haematology and biochemistry).
• Change in vital signs.
• Change in weight

Efficacy, safety and tolerability assessed every 3 months during the extension period

E.5.2.1

Timepoint(s) of evaluation of this end point

weekly

every 3 month during extension period

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-06-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-03-30

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