A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis

NCT03591887 | Completed Phase 2

• 2 other identifiers: ABY-035-0022017-001615-36
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 18

Brief Summary

This randomized, double-blinded dose-finding study evaluates four dose levels of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis. The study consists of 52-week Core study and two optional 52-week periods, Extension and Prolongation of Extension. The Core study consists of three periods: Induction (placebo-controlled, Week 0-12), Optimization (Week 12-24), and Individualization (Week 24-52).

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with a ≥90% improvement in Psoriasis Area and Severity Index (PASI90) at week 12

  The PASI combines the extent of body surface involvement in the body regions head, trunk, arms, and legs. The percent area of the skin involved is estimated per region (0-100%). The severity is estimated by clinical signs of erythema, induration and scaling, from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). PASI90 is a ≥90% reduction from Baseline in PASI score

  12 weeks

Secondary Outcomes (88)

• Number of treatment emergent Adverse Events

  52 weeks

• Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 24

  24 weeks

• Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 52

  52 weeks

• Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 12

  12 weeks

• Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 24

  24 weeks

Study Arms (5)

ABY-035 2 mg

EXPERIMENTAL

2 mg ABY-035 SC

Biological: ABY-035

ABY-035 20 mg

EXPERIMENTAL

20 mg ABY-035 SC

Biological: ABY-035

ABY-035 80 mg

EXPERIMENTAL

80 mg ABY-035 SC

Biological: ABY-035

ABY-035 160 mg

EXPERIMENTAL

160 mg ABY-035 SC

Biological: ABY-035

Placebo

PLACEBO COMPARATOR

Placebo, switching to 80 mg ABY-035 after 12 weeks

Biological: Placebo

Interventions

ABY-035 BIOLOGICAL

ABY-035 solution for injection

ABY-035 160 mg; ABY-035 2 mg; ABY-035 20 mg; ABY-035 80 mg

Placebo BIOLOGICAL

Placebo to ABY-035 solution for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with plaque psoriasis of at least 6 months prior to Screening, without clinically significant flares during the 12 weeks before randomization, with or without psoriatic arthritis
• Having precedent failure, intolerance and/or contraindication to at least two standard therapies for moderate to-severe plaque psoriasis (systemic therapy and/or phototherapy), and previousinsufficient disease control of topical therapy (e.g. corticosteroids, vitamin D derivatives, cignolin/dithranol).
• Moderate-to-severe plaque psoriasis at Screening and at Baseline as defined by:
• i. Psoriasis involving ≥10% BSA ii. PASI score of ≥ 12 iii. sPGA score of ≥ 3
• Use of highly effective method of contraception or female of non-childbearing potential

You may not qualify if:

• Current forms of psoriasis other than chronic plaque-type
• Current drug induced psoriasis
• History of hypersensitivity or allergy to the IMP or its excipients
• History of recurrent or medically important infections requiring intervention and/or systemic treatment in the last 12 months, including infections with e.g. candida and Staphylococcus aureus
• History of 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)
• Autoimmune disease of relevance
• Inflammatory Bowel Disease requiring treatment within the past 12 months
• Clinically significant heart condition which is not well controlled by current therapy, as assessed by the Investigator
• Significantly immunocompromised subject
• Blood pressure out of range
• Laboratory values out of range, including ALT, AST, eGFR
• Positive to HIV, hepatitis B, hepatitis C or tuberculosis
• Recent previous psoriasis treatments, within defined wash-out periods
• Prior exposure to systemic psoriasis treatments with anti-IL-17 biological therapies
• Live vaccination within defined time restrictions

Sponsors & Collaborators

• Affibody: lead
• TFS Trial Form Support: collaborator

Study Sites (18)

Rothhaar Studien GmbH

Berlin, 10783, Germany

Location

Praxis für Haut- und Geschlechtskrankheiten im Ärztehaus "Rudolf Virchow"

Berlin, 13055, Germany

Location

Hautzentrum Weissensee

Berlin, 13086, Germany

Location

Hautarztzentrum Tegel

Berlin, 13507, Germany

Location

Klinik für Dermatologie, Venerologie und Allergologie der Ruhr-Universität

Bochum, 44791, Germany

Location

Hautarztpraxis im Jahrhunderthaus

Bochum, 44793, Germany

Location

RuhrDerm - Studienzentrum der Gemeinschaftspraxis für Dermatologie, Venerologie, Allergologie, Phlebologie

Bochum, 44803, Germany

Location

Elbe Kliniken Buxtehude

Buxtehude, 21615, Germany

Location

Rosenpark Research

Darmstadt, 64283, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212, Germany

Location

Derma-Study-Center FN GmbH

Friedrichshafen, 88045, Germany

Location

SCIderm Clinics

Hamburg, 20354, Germany

Location

Klinik für Dermatologie, Venerologie und Allergologie

Kiel, 24105, Germany

Location

Dermatologische Gemeinschaftspraxis

Mahlow, 15831, Germany

Location

Clinical research center (CRC) Department of Dermatology

Mainz, 55131, Germany

Location

Dres. Unnewehr

Osnabrück, 49078, Germany

Location

CMS³ - Company for Medical Study & Service Selters UG

Selters, 56242, Germany

Location

CentroDerm GmbH

Wuppertal, 42287, Germany

Location

Study Officials

• Sascha Gerdes, Dr. med

  Klinik für Dermatologie, Venerologie und Allergologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 19, 2018
• Study Start: March 7, 2018
• Primary Completion: March 27, 2019
• Study Completion: December 3, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (18)