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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001615-36 | EudraCT Number |
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| Name | Class |
|---|---|
| TFS Trial Form Support | INDUSTRY |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABY-035 2 mg | Experimental | 2 mg ABY-035 SC |
|
| ABY-035 20 mg | Experimental | 20 mg ABY-035 SC |
|
| ABY-035 80 mg | Experimental | 80 mg ABY-035 SC |
|
| ABY-035 160 mg | Experimental | 160 mg ABY-035 SC |
|
| Placebo | Placebo Comparator | Placebo, switching to 80 mg ABY-035 after 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABY-035 | Biological | ABY-035 solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent Adverse Events | Adverse Events starting after first administration of study drug | 52 weeks |
| Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 24 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Sascha Gerdes, Dr. med | Klinik für Dermatologie, Venerologie und Allergologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothhaar Studien GmbH | Berlin | 10783 | Germany | |||
| Praxis für Haut- und Geschlechtskrankheiten im Ärztehaus "Rudolf Virchow" |
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| Placebo | Biological | Placebo to ABY-035 solution for injection |
|
A ≥90% reduction from Baseline in PASI score
| 24 weeks |
| Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 52 | A ≥90% reduction from Baseline in PASI score | 52 weeks |
| Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 12 | A ≥50% reduction from Baseline in PASI score | 12 weeks |
| Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 24 | A ≥50% reduction from Baseline in PASI score | 24 weeks |
| Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 52 | A ≥50% reduction from Baseline in PASI score | 52 weeks |
| Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 12 | A ≥75% reduction from Baseline in PASI score | 12 weeks |
| Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 24 | A ≥75% reduction from Baseline in PASI score | 24 weeks |
| Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 52 | A ≥75% reduction from Baseline in PASI score | 52 weeks |
| Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 12 | A 100% reduction from Baseline in PASI score | 12 weeks |
| Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 24 | A 100% reduction from Baseline in PASI score | 24 weeks |
| Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 52 | A 100% reduction from Baseline in PASI score | 52 weeks |
| Change from baseline in PASI score at week 12 | PASI: Psoriasis Area and Severity Index | Week 12 |
| Change from baseline in PASI score at week 24 | PASI: Psoriasis Area and Severity Index | Week 24 |
| Change from baseline in PASI score at week 52 | PASI: Psoriasis Area and Severity Index | Week 52 |
| Proportion of subjects achieving an absolute PASI score ≤1 at week 12 | PASI ≤1 equals clear or almost clear skin | 12 weeks |
| Proportion of subjects achieving an absolute PASI score ≤1 at week 24 | PASI ≤1 equals clear or almost clear skin | 24 weeks |
| Proportion of subjects achieving an absolute PASI score ≤1 at week 52 | PASI ≤1 equals clear or almost clear skin | 52 weeks |
| Proportion of subjects achieving an absolute PASI score <3 at week 12 | PASI: Psoriasis Area and Severity Index | 12 weeks |
| Proportion of subjects achieving an absolute PASI score <3 at week 24 | PASI: Psoriasis Area and Severity Index | 24 weeks |
| Proportion of subjects achieving an absolute PASI score <3 at week 52 | PASI: Psoriasis Area and Severity Index | 52 weeks |
| Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 12 | The sPGA is the physician's determination of the subject's Psoriasis lesions overall at a given time point, with the grading 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe) | 12 weeks |
| Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 24 | sPGA: Static Physician's Global Assessment | 24 weeks |
| Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 52 | sPGA: Static Physician's Global Assessment | 52 weeks |
| Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 12 | sPGA: Static Physician's Global Assessment | 12 weeks |
| Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 24 | sPGA: Static Physician's Global Assessment | 24 weeks |
| Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 52 | sPGA: Static Physician's Global Assessment | 52 weeks |
| Change from baseline in sPGA at week 12 | sPGA: Static Physician's Global Assessment | 12 weeks |
| Change from baseline in sPGA at week 24 | sPGA: Static Physician's Global Assessment | 24 weeks |
| Change from baseline in sPGA at week 52 | sPGA: Static Physician's Global Assessment | 52 weeks |
| Change from baseline in target nail Nail Psoriasis Severity Index (NAPSI) at week 12 | The NAPSI scale is used to evaluate the severity of psoriasis in the fingernail bed and matrix. The nail is divided into quadrants. Each quadrant is given the score 0 (absence) or 1 (presence) for psoriasis in the beds and matrix, respectively. The NAPSI score of a nail is the sum of each quadrant. The maximum score per nail is 8. In the target nail NAPSI, the worst affected nail at Baseline is evaluated throughout the study. | Week 12 |
| Change from baseline in target nail NAPSI at week 24 | NAPSI: Nail Psoriasis Severity Index | Week 24 |
| Change from baseline in target nail NAPSI at week 52 | NAPSI: Nail Psoriasis Severity Index | Week 52 |
| Proportion of subjects achieving Dermatology Life Quality Index (DLQI) of 0 or 1 at week 12 | DLQI is a 10-question quality-of-life questionnaire completed by the subject. It covers 6 the domains symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The total scores range from 0 to 30, with higher score indicating greater quality of life impairment. | Week 12 |
| Proportion of subjects achieving DLQI of 0 or 1 at week 24 | DLQI: Dermatology Life Quality Index | Week 24 |
| Proportion of subjects achieving DLQI of 0 or 1 at week 52 | DLQI: Dermatology Life Quality Index | Week 52 |
| Proportion of subjects achieving DLQI of ≤ 5 at Week 12 | DLQI: Dermatology Life Quality Index | Week 12 |
| Proportion of subjects achieving DLQI of ≤ 5 at Week 24 | DLQI: Dermatology Life Quality Index | Week 24 |
| Proportion of subjects achieving DLQI of ≤ 5 at Week 52 | DLQI: Dermatology Life Quality Index | Week 52 |
| Change from baseline in DLQI at week 12 | DLQI: Dermatology Life Quality Index | Week 12 |
| DLQI at week 24 compared to baseline | DLQI: Dermatology Life Quality Index | Week 24 |
| DLQI at week 52 compared to baseline | DLQI: Dermatology Life Quality Index | Week 52 |
| Change from baseline in pain-Visual Analogue Scale (VAS) at week 12 | Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain) | Week 12 |
| Pain-VAS score at Week 24 compared to baseline | Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain) | Week 24 |
| Pain-VAS score at Week 52 compared to baseline | Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain) | Week 52 |
| Change from baseline in itch-Visual Analogue Scale (VAS) at week 12 | Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch) | Week 12 |
| Itch-VAS at week 24 compared to baseline | Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch) | Week 24 |
| Itch-VAS at week 52 compared to baseline | Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch) | Week 52 |
| Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 | AUC is a measure of the drug exposure | 52 weeks |
| Levels of anti-ABY-035 antibodies in serum | Anti-drug antibodies | 52 weeks |
| Number of treatment emerging Adverse Events during the Extension period | Adverse Events starting after first administration of study drug | Week 52 to Week 104 |
| Number of treatment emerging Adverse Events during the Prolongation of Extension period | Adverse Events starting after first administration of study drug | Week 104 to Week 156 |
| Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 during the Extension period | AUC is a measure of the drug exposure | Week 52 to Week 104 |
| Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 during the Prolongation of Extension period | AUC is a measure of the drug exposure | Week 104 to Week 156 |
| Levels of anti-ABY-035 antibodies in serum during the Extension period | Anti-drug antibodies | Week 52 to Week 104 |
| Levels of anti-ABY-035 antibodies in serum during the Prolongation of Extension period | Anti-drug antibodies | Week 104 to Week 156 |
| Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at end of Extension period | A ≥90% reduction from Baseline in PASI score | Week 104 |
| Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at end of Prolongation of Extension period | A ≥90% reduction from Baseline in PASI score | Week 156 |
| Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at end of Extension period | A ≥50% reduction from Baseline in PASI score | Week 104 |
| Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at end of Prolongation of Extension period | A ≥50% reduction from Baseline in PASI score | Week 156 |
| Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at end of Extension period | A ≥75% reduction from Baseline in PASI score | Week 104 |
| Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at end of Prolongation of Extension period | A ≥75% reduction from Baseline in PASI score | Week 156 |
| Proportion of subjects achieving a 100% improvement in PASI (PASI100) at end of Extension period | A 100% reduction from Baseline in PASI score | Week 104 |
| Proportion of subjects achieving a 100% improvement in PASI (PASI100) at end of Prolongation of Extension period | A 100% reduction from Baseline in PASI score | Week 156 |
| Change from baseline in PASI score at end of Extension period | PASI: Psoriasis Area and Severity Index | Week 104 |
| Change from baseline in PASI score at end of Prolongation of Extension period | PASI: Psoriasis Area and Severity Index | Week 156 |
| Proportion of subjects achieving an absolute PASI score ≤1 at end of Extension period | PASI ≤1 equals clear or almost clear skin | Week 104 |
| Proportion of subjects achieving an absolute PASI score ≤1 at end of Prolongation of Extension period | PASI ≤1 equals clear or almost clear skin | Week 156 |
| Proportion of subjects achieving an absolute PASI score <3 at end of Extension period | PASI: Psoriasis Area and Severity Index | Week 104 |
| Proportion of subjects achieving an absolute PASI score <3 at end of Prolongation of Extension period | PASI: Psoriasis Area and Severity Index | Week 156 |
| Proportion of subjects achieving sPGA of 0 or 1 at end of Extension period | sPGA: Static Physician's Global Assessment | Week 104 |
| Proportion of subjects achieving sPGA of 0 or 1 at end of Prolongation of Extension period | sPGA: Static Physician's Global Assessment | Week 156 |
| Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at end of Extension period | sPGA: Static Physician's Global Assessment | Week 104 |
| Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at end of Prolongation of Extension period | sPGA: Static Physician's Global Assessment | Week 156 |
| Change from baseline in sPGA at end of Extension period | sPGA: Static Physician's Global Assessment | Week 104 |
| Change from baseline in sPGA at end of Prolongation Extension period | sPGA: Static Physician's Global Assessment | Week 156 |
| Change from baseline in target nail NAPSI at end of Extension period | NAPSI: Nail Psoriasis Severity Index | Week 104 |
| Change from baseline in target nail NAPSI at end of Prolongation of Extension period | NAPSI: Nail Psoriasis Severity Index | Week 156 |
| Proportion of subjects achieving DLQI of 0 or 1 at end of Extension period | DLQI: Dermatology Life Quality Index | Week 104 |
| Proportion of subjects achieving DLQI of 0 or 1 at end of Prolongation of Extension period | DLQI: Dermatology Life Quality Index | Week 156 |
| Proportion of subjects achieving DLQI of ≤ 5 at end of Extension period | DLQI: Dermatology Life Quality Index | Week 104 |
| Proportion of subjects achieving DLQI of ≤ 5 at end of Prolongation of Extension period | DLQI: Dermatology Life Quality Index | Week 156 |
| DLQI at end of Extension period compared to baseline | DLQI: Dermatology Life Quality Index | Week 104 |
| DLQI at end of Prolongation of Extension period compared to baseline | DLQI: Dermatology Life Quality Index | Week 156 |
| Pain-VAS score at end of Extension period compared to baseline | Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain) | Week 104 |
| Pain-VAS at end of Prolongation of Extension period compared to baseline | Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain) | Week 156 |
| Itch-VAS at end of Extension period compared to baseline | Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch) | Week 104 |
| Itch-VAS at end of Prolongation of Extension period compared to baseline | Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch) | Week 156 |
| Berlin |
| 13055 |
| Germany |
| Hautzentrum Weissensee | Berlin | 13086 | Germany |
| Hautarztzentrum Tegel | Berlin | 13507 | Germany |
| Klinik für Dermatologie, Venerologie und Allergologie der Ruhr-Universität | Bochum | 44791 | Germany |
| Hautarztpraxis im Jahrhunderthaus | Bochum | 44793 | Germany |
| RuhrDerm - Studienzentrum der Gemeinschaftspraxis für Dermatologie, Venerologie, Allergologie, Phlebologie | Bochum | 44803 | Germany |
| Elbe Kliniken Buxtehude | Buxtehude | 21615 | Germany |
| Rosenpark Research | Darmstadt | 64283 | Germany |
| Privatpraxis Dr. Hilton & Partner | Düsseldorf | 40212 | Germany |
| Derma-Study-Center FN GmbH | Friedrichshafen | 88045 | Germany |
| SCIderm Clinics | Hamburg | 20354 | Germany |
| Klinik für Dermatologie, Venerologie und Allergologie | Kiel | 24105 | Germany |
| Dermatologische Gemeinschaftspraxis | Mahlow | 15831 | Germany |
| Clinical research center (CRC) Department of Dermatology | Mainz | 55131 | Germany |
| Dres. Unnewehr | Osnabrück | 49078 | Germany |
| CMS³ - Company for Medical Study & Service Selters UG | Selters | 56242 | Germany |
| CentroDerm GmbH | Wuppertal | 42287 | Germany |