A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis
NCT ID: NCT03591887
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2018-03-07
2021-12-03
Brief Summary
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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).
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Detailed Description
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* Induction (Week 0-12) - four dose levels and placebo (Q2W)
* Optimization (Week 12-24) - starting with a possible dose adjustment (all subjects on Q2W) depending on PASI score. Subjects on placebo switch to active drug (Q4W).
* Individualization (Week 24-52) - starting with a switch to Q4W for all subjects. From week 32 dosing interval alters depending on PASI score.
The study is unblinded after completion of the Core study. During the optional Extension and Prolongation of Extension periods, dose levels and intervals alter depending on PASI score.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABY-035 2 mg
2 mg ABY-035 SC
ABY-035
ABY-035 solution for injection
ABY-035 20 mg
20 mg ABY-035 SC
ABY-035
ABY-035 solution for injection
ABY-035 80 mg
80 mg ABY-035 SC
ABY-035
ABY-035 solution for injection
ABY-035 160 mg
160 mg ABY-035 SC
ABY-035
ABY-035 solution for injection
Placebo
Placebo, switching to 80 mg ABY-035 after 12 weeks
Placebo
Placebo to ABY-035 solution for injection
Interventions
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ABY-035
ABY-035 solution for injection
Placebo
Placebo to ABY-035 solution for injection
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Inability or unwillingness to limit ultraviolet (UV) light exposure during the course of the study
* Pregnancy, breast feeding
* Drug and/or alcohol abuse or dependence
18 Years
65 Years
ALL
No
Sponsors
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TFS Trial Form Support
INDUSTRY
Affibody
INDUSTRY
Responsible Party
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Principal Investigators
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Sascha Gerdes, Dr. med
Role: PRINCIPAL_INVESTIGATOR
Klinik für Dermatologie, Venerologie und Allergologie
Locations
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Rothhaar Studien GmbH
Berlin, , Germany
Praxis für Haut- und Geschlechtskrankheiten im Ärztehaus "Rudolf Virchow"
Berlin, , Germany
Hautzentrum Weissensee
Berlin, , Germany
Hautarztzentrum Tegel
Berlin, , Germany
Klinik für Dermatologie, Venerologie und Allergologie der Ruhr-Universität
Bochum, , Germany
Hautarztpraxis im Jahrhunderthaus
Bochum, , Germany
RuhrDerm - Studienzentrum der Gemeinschaftspraxis für Dermatologie, Venerologie, Allergologie, Phlebologie
Bochum, , Germany
Elbe Kliniken Buxtehude
Buxtehude, , Germany
Rosenpark Research
Darmstadt, , Germany
Privatpraxis Dr. Hilton & Partner
Düsseldorf, , Germany
Derma-Study-Center FN GmbH
Friedrichshafen, , Germany
SCIderm Clinics
Hamburg, , Germany
Klinik für Dermatologie, Venerologie und Allergologie
Kiel, , Germany
Dermatologische Gemeinschaftspraxis
Mahlow, , Germany
Clinical research center (CRC) Department of Dermatology
Mainz, , Germany
Dres. Unnewehr
Osnabrück, , Germany
CMS³ - Company for Medical Study & Service Selters UG
Selters, , Germany
CentroDerm GmbH
Wuppertal, , Germany
Countries
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Other Identifiers
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2017-001615-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABY-035-002
Identifier Type: -
Identifier Source: org_study_id
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