moderate-to-severe plaque psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: ABY-035
Pharmaceutical Form: Solution for injection
INN or Proposed INN: izokibep
CAS Number: 2226130-02-3
Current Sponsor code: ABY-035
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Affibody AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willingness and capability of providing written Informed Consent 2. Male or female, aged 18-75 years (inclusive), and of any origin 3.Diagnosed with plaque psoriasis of at least 6 months prior to Screening, suitable for systemic treatment or phototherapy, and has stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before randomization). Subjects with low active Psoriatic Arthritis may be included if they had not received systemic treatment within the last 12 months 4. 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 previous insufficient disease control of topical therapy (e.g. corticosteroids, vitamin D derivatives, cignolin/dithranol) 5. 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 6. Willingness and capability of using adequate contraceptive measures from Screening visit until the Pregnancy follow-up Visit: i. Female subject of childbearing potential using a highly efficient method of contraception OR female subjects 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]) ii. Male subject, and their female partner of childbearing potential, using a highly efficient method of contraception iii. Adequate contraceptive method defined as: a. A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner) OR b. 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]) 7. Willingness and capability of complying with all study procedure requirements, as per the Investigator’s judgment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Current forms of psoriasis other than chronic plaque-type 2. Current drug induced psoriasis 3. History of hypersensitivity or allergy to the IMP or its excipients 4. History of recurrent or medically important infections in the last 12 months that required medical/pharmaceutical intervention 5. Clinically significant candida infection requiring systemic treatment within last 12 months 6. Clinically significant skin infection with Staphylococcus aureus requiring systemic treatment within the last 12 months 7. 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) 8. History of or current relevant autoimmune diseases other than psoriasis 9. Diagnosis of Inflammatory Bowel Disease requiring treatment within the past 12 months 10. Clinically significant heart condition which is not well controlled by current therapy, as assessed by the Investigator 11. Underlying conditions which in the opinion of the Investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy 12. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the subject from adhering to the protocol or completing the study per protocol 13. Current uncontrolled arterial hyper- or hypotension as evidenced by measured blood pressure values at Screening (after 15 min in supine position) outside the following ranges: -Systolic blood pressure: =90 mmHg or > 140 mmHg -Diastolic blood pressure: =50 mmHg or =95 mmHg 14. Alanine aminotransferase or aspartate aminotransferase level =2.5 times the upper limit of normal at Screening 15. Estimated Glomerular Filtration Rate <60 mL/min/1.73 m2 according to the CKD-EPI equation 16. Positive test for subclinical / latent tuberculosis infection at Screening 17. Positive test for human immunodeficiency virus, hepatitis B or hepatitis C at Screening: -HIV antibody (any test) -HBV surface antigen -Anti-HCV antibody 18. Women who are currently pregnant, who intend to become pregnant during the course of the study, or who are breastfeeding 19. Evidence or indication of drug and/or alcohol abuse or dependence, according to the judgment of the Investigator 20. Recent previous exposure to systemic psoriasis treatments within the following weeks prior to randomization: biological therapies (e.g. ustekinumab [16 weeks], adalimumab, alefacept, infliximab [12 weeks], etanercept [6 weeks], experimental biological products [6 months or 5 half-lives, whichever is longer]); immunosuppressive agents [4 weeks]; other medications affecting the immune function [4 weeks]; rituximab [52 weeks]; or other systemic psoriasis treatments [4 weeks] 21. Treatment with topical agents that could affect psoriasis activity within 2 weeks of randomization. Topical therapy in selected areas such as the groin or axillar region with mild corticosteroids (European classification 1) is not excluded 22. Prior exposure to systemic psoriasis treatments with anti-IL-17 biological therapies 23. Photochemotherapy, phototherapy, or blue light therapy within 4 weeks of randomization 24. Use of any prescribed or non-prescribed systemic or topical medication within 7 days of randomization that, in the opinion of the Investigator, may affect the study assessments or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, defined as Psoriasis Area and Severity Index (PASI) 90 response, of different dose levels of ABY-035 compared to placebo in subjects with moderate-to-severe plaque psoriasis after 12 weeks of treatment.;Secondary Objective: 1. Evaluate safety, tolerability of ABY-035 2. Evaluate efficacy of ABY-035 vs placebo after 12w treatment 3. Evaluate efficacy, defined as PASI 90 response, of different dosing regimens of ABY-035 in subjects with moderate-to-severe plaque psoriasis after 24, 52, 76, 104, 128, 156, 180, 208, 232, 260 w of treatment 4. Evaluate efficacy, defined as PASI 50, 75 and 100 responses, absolute PASI scores, sPGA scores, target NAPSI scores of different ABY-035 dosing regimens in subjects with moderate-to-severe plaque psoriasis after 12, 24, 52, 76, 104, 128 156, 180, 208, 232 and 260 w of treatment (NAPSI scores not evaluated at W 76, 128, 180, 232) 5. Evaluate change in PROs, using the DLQI, the pain-VAS and the itch-VAS following 12, 24, 52, 76, 104, 128, 156, 180, 208, 232 and 260 w of treatment with different ABY-035 dosing regimens in subjects with moderate-to-severe plaque psoriasis 6. Evaluate PK of ABY-035 after multiple subcutaneous dosing 7. Assess immunogenicity of ABY-035;Primary end point(s): Proportion of subjects at each dose level who achieve a =90% reduction in PASI score (PASI 90 response) at Week 12 of the Core study;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety as assessed by vital signs, physical examination, safety laboratory and adverse events (AEs) 2.1. Difference to placebo per dose level in the proportion of subjects achieving PASI 50, 75, 90 and 100 responses, absolute PASI score < 3 and =1, sPGA of 0 or 1 and =2-point improvement from Baseline, DLQI of 0 or 1 after 12 weeks of treatment of the Core study 2.2. Difference to placebo per dosing regimen in change from Baseline in absolute PASI score, sPGA, target nail NAPSI, DLQI, Pain-VAS and Itch-VAS after 12 weeks of treatment of the Core study 3. Proportion of subjects per dosing regimen achieving PASI 90 response at Week 24 and 52 of the Core study 4.1. Proportion of subjects per dosing regimen achieving PASI 50, 75, and 100 responses at Week 12, 24 and 52 of the Core study 4.2. Proportion of subjects per dosing regimen achieving absolute PASI < 3 response at Week 12, 24 and 52 of the Core study 4.3. Proportion of subjects per dosing regimen achieving absolute PASI =1 response at Week 12, 24 and 52 of the Core study 4.4. Change from Baseline to Week 12, 24 and 52 of the Core study in PASI score 4.5. Proportion of subjects per dosing regimen achieving sPGA of 0 or 1 and =2-point improvement from Baseline at Week 12, 24 and 52 of the Core study 4.6. Change from Baseline to Week 12, 24 and 52 of the Core study in sPGA score 4.7. Change from Baseline to Week 12, 24 and 52 of the Core study in target nail NAPSI score 5.1. Proportion of subjects per dosing regimen achieving DLQI of 0 or 1 at Week 12, 24 and 52 of the Core study, compared to the proportion of subjects scoring DLQI 0 or 1 at Baseline (Visit 2) 5.2. Proportion of subjects per dosing regimen achieving DLQI of = 5 at Week 12, 24 and 52 of the Core study, compared to the proportion of subjects scoring DLQI = 5 at Baseline (Visit 2) 5.3. DLQI score at Week 12, 24 and 52 of the Core study compared to Baseline (Visit 2) 5.4. Pain-VAS score at Week 12, 24 and 52 of the Core study | — |
Countries
Germany
Contacts
Public ContactDirector Regulatory Affairs
Affibody AB
Outcome results
None listed