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

Launched by AFFIBODY · Jul 18, 2018

Keywords

ClinConnect Summary

The Core study evaluates four doses of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis. The treatment periods in the Core study are:

* 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 Cor...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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