NCT02690142

Brief Summary

The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to psoriasis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

January 22, 2016

Last Update Submit

March 1, 2018

Conditions

PsoriasisHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Abnormal Laboratory Values or other Adverse Events

    Safety is monitored by Vital signs, 12-lead ECGs, urinalysis, hematology, clinical chemistry, coagulation, proinflammatory cytokines and CRP

    Follow-up visit (Day 141)

Secondary Outcomes (13)

  • AUC (Area Under the Concentration-time curve) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples

    Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141

  • t1/2 (half-life) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples

    Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141

  • Maximum serum concentration (Cmax) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples

    Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141

  • Time of maximum observed plasma concentration of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples

    Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141

  • Time of last quantifiable plasma concentration of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples

    Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141

  • +8 more secondary outcomes

Study Arms (4)

ABY-035 i.v.

EXPERIMENTAL

Part A: SAD (single ascending dose) including five different dose cohorts. ABY-035 given as intravenous injections. 6 ABY-035 and 2 placebo in each cohort.

Drug: PlaceboDrug: ABY-035 i.v.

ABY-035 s.c.

EXPERIMENTAL

Part B: Bioavailability study where 6 subjects will receive ABY-035 as a single subcutaneous injection.

Drug: ABY-035 s.c.

ABY-035 i.v. in psoriasis patients

EXPERIMENTAL

Part C: Up to 12 psoriasis patients will receive ABY-035 as a single intravenous injection.

Drug: ABY-035 i.v.

ABY-035 s.c. in psoriasis patients

EXPERIMENTAL

Part D: Up to 18 patients will receive 3 or 7 biweekly doses of ABY-035 as s.c. injections

Drug: ABY-035 s.c.

Interventions

PlaceboDRUG

Single dose i.v.

ABY-035 i.v.
ABY-035 i.v.DRUG

Single dose i.v.

ABY-035 i.v.ABY-035 i.v. in psoriasis patients
ABY-035 s.c.DRUG

Single dose s.c.

ABY-035 s.c.ABY-035 s.c. in psoriasis patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part A, Part B
  • Males or females between 18 and 65 years of age
  • Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive. maximum body weight of 120 kg
  • In good health, as determined by medical history, physical examination, vital signs assessment, 12 lead electrocardiogram (ECG) and clinical laboratory evaluations.
  • Subjects will have given their written informed consent to participate in the study
  • In addition for Part C and D
  • Males or females between 18 and 65 years of age
  • Body mass index (BMI) between 18.0 kg/m2 and 39.9 kg/m2, inclusive. Minimum body weight of 45 kg
  • Part C: Patients must have had a diagnosis of moderate to severe plaque type psoriasis at least 6 months prior to administration of the study drug without a documented flare within 30 days prior to Screening. Patients with concurrent psoriatic arthritis may be enrolled.
  • Part D: Patients must have had a diagnosis of plaque type psoriasis (mild, moderate or severe) at least 6 months prior to administration of the study drug without a documented flare within 30 days prior to Screening. Patients with concurrent psoriatic arthritis may be enrolled.
  • Part C: Have plaque type psoriasis covering at least 10% of total body surface area (BSA) at Screening and at Baseline (Day 1) and have a PASI score of 12 or greater at Screening and at Baseline (Day 1).
  • Part D: Have at least one psoriatic lesion

You may not qualify if:

  • Part A, Part B, Part C and Part D
  • Subjects who have any clinically significant medical history, as determined by the investigator
  • Subjects who smoke more than 15 cigarettes, or equivalent, per day
  • Alcohol and/or drug abuse
  • Positive for HIV, Hepatitis B, Hepatitis C, or tuberculosis
  • Subjects who have received a live vaccination within the 3 months prior to Screening
  • Subjects who are pregnant or lactating
  • Subjects who do not agree to use appropriate contraception
  • Subjects who have a history of anaphylaxis, drug allergy or clinically significant allergic condition (excluding non active hayfever)
  • Participation in another clinical trial
  • Subjects who, in the opinion of the investigator, should not participate in this study
  • In addition for Part C and D
  • Patients who currently have non plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
  • Patients who have current drug induced psoriasis
  • Have any history of any use of or have participated in clinical trials for any therapeutic agent directly targeted to any IL 17 cytokine or receptor
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Covance Clinical Research Unit Ltd.

Leeds, LS2 9LH, United Kingdom

Location

Covance and Royal Liverpool University Hospital Clinical Research Unit

Liverpool, L7 8XP, United Kingdom

Location

Imperial Centre for Translational and Experimental Medicine Imperial College Healthcare NHS Trust Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Medicines Evaluation Unit Ltd

Manchester, M23 9QZ, United Kingdom

Location

Related Publications (1)

  • Klint S, Feldwisch J, Gudmundsdotter L, Dillner Bergstedt K, Gunneriusson E, Hoiden Guthenberg I, Wennborg A, Nyborg AC, Kamboj AP, Peloso PM, Bejker D, Frejd FY. Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis. MAbs. 2023 Jan-Dec;15(1):2209920. doi: 10.1080/19420862.2023.2209920.

    PMID: 37184136DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sunu Valasseri, MBBS, MSc

    Covance Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 24, 2016

Study Start

February 1, 2016

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

March 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)