Clinical Trials Register

Summary
EudraCT Number:	2019-003405-94
Sponsor's Protocol Code Number:	ABY-035-202
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-11-22
Trial results	View 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

Czechia - SUKL

A.2

EudraCT number

2019-003405-94

A.3

Full title of the trial

A multicenter, randomized, double-blind, placebo-controlled, dose-finding clinical trial inpatients with active psoriatic arthritis to investigate efficacy, tolerability, safety,
pharmacokinetics and immunogenicity of ABY-035

Multicentrické, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení zaměřené ke stanovení dávky u pacientů s aktivní psoriatickou artritidou za účelem zkoumání účinnosti, snášenlivosti, bezpečnosti, farmakokinetiky a imunogenicity přípravku ABY-035

A.3.1

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

A double-blind study in subjects with active psoriatic arthritis to evaluate efficacy, tolerability, safety of two different dose levels of ABY-035 compared to placebo.

A.4.1

Sponsor's protocol code number

ABY-035-202

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	Affibody AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Affibody AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Affibody AB
B.5.2	Functional name of contact point	Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Scheeles väg 2
B.5.3.2	Town/ city	Solna
B.5.3.3	Post code	SE-171 65
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46 (0)763 49 58 49
B.5.6	E-mail	camilla.sandell@affibody.se

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	ABY-035
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Izokibep
D.3.9.1	CAS number	2226130-02-3
D.3.9.2	Current sponsor code	ABY-035
D.3.9.3	Other descriptive name	Recombinant protein comprising two IL-17A binding domains and an albumin binding domain
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Active Psoriatic Arthritis

E.1.1.1

Medical condition in easily understood language

Psoriatic Arthritis

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate efficacy of different dose regimens of ABY-035 as compared to placebo in patients with active psoriatic arthritis (PsA)

E.2.2

Secondary objectives of the trial

To evaluate further efficacy, tolerability, safety, pharmacokinetics, immunogenicity and pharmacodynamics of two dose regimens of ABY-035

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient who has given his / her signed declaration of consent and data protection declaration
2. At least 18 years and less than 75 years of age at Screening visit
3. Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
4. Active psoriatic arthritis defined by:
a. ≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
b. ≥3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit
5. Precedent failure or insufficient treatment response to at least one of the following psoriatic arthritis treatments:
a. NSAID
b. csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A)
c. TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab)
6. Rheumatoid factor (RF) and anti-CCP antibody negative
7. Presence or history of plaque psoriasis
8. For females of childbearing potential only: Negative serum human chorionic gonadotropin (hCG) test at Screening visit
9. Willingness and capability of using adequate contraceptive methods from the Screening visit until 14 weeks after the last ABY-035 dose:
a. Female of childbearing should use a highly efficient method of contraception (see 9c) but this is not necessary for females of non-childbearing potential permanently sterilized or post-menopausal [i.e. at least 12 consecutive months with amenorrhea without other known or suspected medical cause])
b. Male who has a female partner of childbearing potential, should use a highly efficient method of contraception (see 9c)
c. Adequate contraceptive method defined as:
i. A method with less than 1% failure rate (e.g. permanent sterilization, hormone
implants, hormone injections, some intrauterine devices, or vasectomized partner)
OR
ii. The use of two methods of contraception (e.g. one barrier method [condom,
diaphragm or cervical / vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectables and implants])
10. Willingness and capability of complying with all trial procedure requirements, as per the investigator’s judgement

E.4

Principal exclusion criteria

Principal Exclusion criteria:
1. Underlying conditions which, in the investigator’s opinion, significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
2. History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
3. History of or current fibromyalgia or pain syndrome
4. Uncontrolled inflammatory bowel disease
5. Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit, e.g. due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections, that required medical / pharmaceutical intervention (i.e. prescription of antibiotics and / or hospitalization)
6. Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
7. History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years (with the exception of basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence)
8. Insufficiently controlled heart failure, as assessed by the investigator
9. Current uncontrolled arterial hyper- or hypotension
Laboratory examinations and body measurements:
10. Positive test for subclinical / latent tuberculosis infection (i.e. positive QuantiFERON-TB® Gold test or equivalent product) or chest X-ray suggestive of tuberculosis at Screening visit
11. Positive test for human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) at Screening visit:
a. HIV antibody (any test)
b. HBV surface antigen (HBVsAg)
c. Anti-HCV antibody (HCV Ab)
12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) at Screening visit
13. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation at Screening visit
14. Body mass index (BMI) ≥40 kg/m2 or <16 kg/m2
Medication, drug use and special behavioral patterns
15. Previous exposure to ABY-035 or any other interleukin-(IL-)17i or IL-17 receptor inhibitor (e.g. secukinumab, ixekizumab, brodalumab)
16. History of hypersensitivity or allergy to ABY-035 or its excipients
Refer to Protocol for full list of Exclusion criteria

E.5 End points

E.5.1

Primary end point(s)

Primary Endpoint Family (Efficacy):
● ACR50 response rate at V9 (Week 16) for Higher Dose (80 mg) vs Placebo
● ACR50 response rate at V7 (Week 12) for Higher Dose vs Placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

Primary Endpoint Family (Efficacy) evaluation Timepoint:
● ACR50 response rate at V9 (Week 16) for Higher Dose (80 mg) vs Placebo
● ACR50 response rate at V7 (Week 12) for Higher Dose vs Placebo

E.5.2

Secondary end point(s)

Secondary Endpoint Family (Efficacy):
● ACR20/70 response rate, percentage of patients achieving MDA: at V9/V7 (Week 16/12) for Higher Dose vs Placebo
● ACR20/50/70 response rate, percentage of patients achieving MDA: at V9/V7 (Week 16/12) for Lower Dose vs Placebo
● ACR20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for Higher and Lower Dose vs Placebo

E.5.2.1

Timepoint(s) of evaluation of this end point

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

immunogenicity of ABY-035

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

LSLV

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

105

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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.4.2

For a multinational trial

F.4.2.1

In the EEA

129

F.4.2.2

In the whole clinical trial

129

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)

The choice of further therapy for PsA at the end of the clinical trial depends on the patient's individual
needs and is left at the physician's discretion.

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

2020-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-11

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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