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Completed

NCT Number: NCT03591887

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

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).

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hautarztzentrum Tegel, Berlin, Germany

Loading trial locations.

About this study

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 Core study. During the optional Extension and Prolongation of Extension periods, dose levels and intervals alter depending on PASI score.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABY-035

Biological

ABY-035 solution for injection

Placebo

Biological

Placebo to ABY-035 solution for injection

Primary outcomes

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

    Time frame: 12 weeks

    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

Secondary outcomes

  1. Number of treatment emergent Adverse Events

    Time frame: 52 weeks

    Adverse Events starting after first administration of study drug

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

    Time frame: 24 weeks

    A ≥90% reduction from Baseline in PASI score

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

    Time frame: 52 weeks

    A ≥90% reduction from Baseline in PASI score

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

    Time frame: 12 weeks

    A ≥50% reduction from Baseline in PASI score

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

    Time frame: 24 weeks

    A ≥50% reduction from Baseline in PASI score

  6. Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 52

    Time frame: 52 weeks

    A ≥50% reduction from Baseline in PASI score

  7. Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 12

    Time frame: 12 weeks

    A ≥75% reduction from Baseline in PASI score

  8. Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 24

    Time frame: 24 weeks

    A ≥75% reduction from Baseline in PASI score

  9. Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 52

    Time frame: 52 weeks

    A ≥75% reduction from Baseline in PASI score

  10. Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 12

    Time frame: 12 weeks

    A 100% reduction from Baseline in PASI score

  11. Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 24

    Time frame: 24 weeks

    A 100% reduction from Baseline in PASI score

  12. Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 52

    Time frame: 52 weeks

    A 100% reduction from Baseline in PASI score

  13. Change from baseline in PASI score at week 12

    Time frame: Week 12

    PASI: Psoriasis Area and Severity Index

  14. Change from baseline in PASI score at week 24

    Time frame: Week 24

    PASI: Psoriasis Area and Severity Index

  15. Change from baseline in PASI score at week 52

    Time frame: Week 52

    PASI: Psoriasis Area and Severity Index

  16. Proportion of subjects achieving an absolute PASI score ≤1 at week 12

    Time frame: 12 weeks

    PASI ≤1 equals clear or almost clear skin

  17. Proportion of subjects achieving an absolute PASI score ≤1 at week 24

    Time frame: 24 weeks

    PASI ≤1 equals clear or almost clear skin

  18. Proportion of subjects achieving an absolute PASI score ≤1 at week 52

    Time frame: 52 weeks

    PASI ≤1 equals clear or almost clear skin

  19. Proportion of subjects achieving an absolute PASI score <3 at week 12

    Time frame: 12 weeks

    PASI: Psoriasis Area and Severity Index

  20. Proportion of subjects achieving an absolute PASI score <3 at week 24

    Time frame: 24 weeks

    PASI: Psoriasis Area and Severity Index

  21. Proportion of subjects achieving an absolute PASI score <3 at week 52

    Time frame: 52 weeks

    PASI: Psoriasis Area and Severity Index

  22. Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 12

    Time frame: 12 weeks

    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)

  23. Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 24

    Time frame: 24 weeks

    sPGA: Static Physician's Global Assessment

  24. Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 52

    Time frame: 52 weeks

    sPGA: Static Physician's Global Assessment

  25. Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 12

    Time frame: 12 weeks

    sPGA: Static Physician's Global Assessment

  26. Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 24

    Time frame: 24 weeks

    sPGA: Static Physician's Global Assessment

  27. Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 52

    Time frame: 52 weeks

    sPGA: Static Physician's Global Assessment

  28. Change from baseline in sPGA at week 12

    Time frame: 12 weeks

    sPGA: Static Physician's Global Assessment

  29. Change from baseline in sPGA at week 24

    Time frame: 24 weeks

    sPGA: Static Physician's Global Assessment

  30. Change from baseline in sPGA at week 52

    Time frame: 52 weeks

    sPGA: Static Physician's Global Assessment

  31. Change from baseline in target nail Nail Psoriasis Severity Index (NAPSI) at week 12

    Time frame: 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.

  32. Change from baseline in target nail NAPSI at week 24

    Time frame: Week 24

    NAPSI: Nail Psoriasis Severity Index

  33. Change from baseline in target nail NAPSI at week 52

    Time frame: Week 52

    NAPSI: Nail Psoriasis Severity Index

  34. Proportion of subjects achieving Dermatology Life Quality Index (DLQI) of 0 or 1 at week 12

    Time frame: 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.

  35. Proportion of subjects achieving DLQI of 0 or 1 at week 24

    Time frame: Week 24

    DLQI: Dermatology Life Quality Index

  36. Proportion of subjects achieving DLQI of 0 or 1 at week 52

    Time frame: Week 52

    DLQI: Dermatology Life Quality Index

  37. Proportion of subjects achieving DLQI of ≤ 5 at Week 12

    Time frame: Week 12

    DLQI: Dermatology Life Quality Index

  38. Proportion of subjects achieving DLQI of ≤ 5 at Week 24

    Time frame: Week 24

    DLQI: Dermatology Life Quality Index

  39. Proportion of subjects achieving DLQI of ≤ 5 at Week 52

    Time frame: Week 52

    DLQI: Dermatology Life Quality Index

  40. Change from baseline in DLQI at week 12

    Time frame: Week 12

    DLQI: Dermatology Life Quality Index

  41. DLQI at week 24 compared to baseline

    Time frame: Week 24

    DLQI: Dermatology Life Quality Index

  42. DLQI at week 52 compared to baseline

    Time frame: Week 52

    DLQI: Dermatology Life Quality Index

  43. Change from baseline in pain-Visual Analogue Scale (VAS) at week 12

    Time frame: Week 12

    Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain)

  44. Pain-VAS score at Week 24 compared to baseline

    Time frame: Week 24

    Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain)

  45. Pain-VAS score at Week 52 compared to baseline

    Time frame: Week 52

    Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain)

  46. Change from baseline in itch-Visual Analogue Scale (VAS) at week 12

    Time frame: Week 12

    Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch)

  47. Itch-VAS at week 24 compared to baseline

    Time frame: Week 24

    Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch)

  48. Itch-VAS at week 52 compared to baseline

    Time frame: Week 52

    Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch)

  49. Pharmacokinetics: Area Under the Curve (AUC) of ABY-035

    Time frame: 52 weeks

    AUC is a measure of the drug exposure

  50. Levels of anti-ABY-035 antibodies in serum

    Time frame: 52 weeks

    Anti-drug antibodies

  51. Number of treatment emerging Adverse Events during the Extension period

    Time frame: Week 52 to Week 104

    Adverse Events starting after first administration of study drug

  52. Number of treatment emerging Adverse Events during the Prolongation of Extension period

    Time frame: Week 104 to Week 156

    Adverse Events starting after first administration of study drug

  53. Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 during the Extension period

    Time frame: Week 52 to Week 104

    AUC is a measure of the drug exposure

  54. Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 during the Prolongation of Extension period

    Time frame: Week 104 to Week 156

    AUC is a measure of the drug exposure

  55. Levels of anti-ABY-035 antibodies in serum during the Extension period

    Time frame: Week 52 to Week 104

    Anti-drug antibodies

  56. Levels of anti-ABY-035 antibodies in serum during the Prolongation of Extension period

    Time frame: Week 104 to Week 156

    Anti-drug antibodies

  57. Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at end of Extension period

    Time frame: Week 104

    A ≥90% reduction from Baseline in PASI score

  58. Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at end of Prolongation of Extension period

    Time frame: Week 156

    A ≥90% reduction from Baseline in PASI score

  59. Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at end of Extension period

    Time frame: Week 104

    A ≥50% reduction from Baseline in PASI score

  60. Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at end of Prolongation of Extension period

    Time frame: Week 156

    A ≥50% reduction from Baseline in PASI score

  61. Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at end of Extension period

    Time frame: Week 104

    A ≥75% reduction from Baseline in PASI score

  62. Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at end of Prolongation of Extension period

    Time frame: Week 156

    A ≥75% reduction from Baseline in PASI score

  63. Proportion of subjects achieving a 100% improvement in PASI (PASI100) at end of Extension period

    Time frame: Week 104

    A 100% reduction from Baseline in PASI score

  64. Proportion of subjects achieving a 100% improvement in PASI (PASI100) at end of Prolongation of Extension period

    Time frame: Week 156

    A 100% reduction from Baseline in PASI score

  65. Change from baseline in PASI score at end of Extension period

    Time frame: Week 104

    PASI: Psoriasis Area and Severity Index

  66. Change from baseline in PASI score at end of Prolongation of Extension period

    Time frame: Week 156

    PASI: Psoriasis Area and Severity Index

  67. Proportion of subjects achieving an absolute PASI score ≤1 at end of Extension period

    Time frame: Week 104

    PASI ≤1 equals clear or almost clear skin

  68. Proportion of subjects achieving an absolute PASI score ≤1 at end of Prolongation of Extension period

    Time frame: Week 156

    PASI ≤1 equals clear or almost clear skin

  69. Proportion of subjects achieving an absolute PASI score <3 at end of Extension period

    Time frame: Week 104

    PASI: Psoriasis Area and Severity Index

  70. Proportion of subjects achieving an absolute PASI score <3 at end of Prolongation of Extension period

    Time frame: Week 156

    PASI: Psoriasis Area and Severity Index

  71. Proportion of subjects achieving sPGA of 0 or 1 at end of Extension period

    Time frame: Week 104

    sPGA: Static Physician's Global Assessment

  72. Proportion of subjects achieving sPGA of 0 or 1 at end of Prolongation of Extension period

    Time frame: Week 156

    sPGA: Static Physician's Global Assessment

  73. Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at end of Extension period

    Time frame: Week 104

    sPGA: Static Physician's Global Assessment

  74. Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at end of Prolongation of Extension period

    Time frame: Week 156

    sPGA: Static Physician's Global Assessment

  75. Change from baseline in sPGA at end of Extension period

    Time frame: Week 104

    sPGA: Static Physician's Global Assessment

  76. Change from baseline in sPGA at end of Prolongation Extension period

    Time frame: Week 156

    sPGA: Static Physician's Global Assessment

  77. Change from baseline in target nail NAPSI at end of Extension period

    Time frame: Week 104

    NAPSI: Nail Psoriasis Severity Index

  78. Change from baseline in target nail NAPSI at end of Prolongation of Extension period

    Time frame: Week 156

    NAPSI: Nail Psoriasis Severity Index

  79. Proportion of subjects achieving DLQI of 0 or 1 at end of Extension period

    Time frame: Week 104

    DLQI: Dermatology Life Quality Index

  80. Proportion of subjects achieving DLQI of 0 or 1 at end of Prolongation of Extension period

    Time frame: Week 156

    DLQI: Dermatology Life Quality Index

  81. Proportion of subjects achieving DLQI of ≤ 5 at end of Extension period

    Time frame: Week 104

    DLQI: Dermatology Life Quality Index

  82. Proportion of subjects achieving DLQI of ≤ 5 at end of Prolongation of Extension period

    Time frame: Week 156

    DLQI: Dermatology Life Quality Index

  83. DLQI at end of Extension period compared to baseline

    Time frame: Week 104

    DLQI: Dermatology Life Quality Index

  84. DLQI at end of Prolongation of Extension period compared to baseline

    Time frame: Week 156

    DLQI: Dermatology Life Quality Index

  85. Pain-VAS score at end of Extension period compared to baseline

    Time frame: Week 104

    Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain)

  86. Pain-VAS at end of Prolongation of Extension period compared to baseline

    Time frame: Week 156

    Pain-VAS: A patient measurement of level pain, from 0 (no pain) to 100 (worst possible pain)

  87. Itch-VAS at end of Extension period compared to baseline

    Time frame: Week 104

    Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch)

  88. Itch-VAS at end of Prolongation of Extension period compared to baseline

    Time frame: Week 156

    Itch-VAS: A patient measurement of level itching from 0 (no itch) to 100 (worst possible itch)

Sponsors and collaborators

Lead sponsor

Affibody

Industry

Collaborators

  • TFS Trial Form Support

Registry information

Official study title

A Phase II, Randomized, Parallel Group, Placebo-controlled, Double-blinded, Dose-finding Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis

Acronym: AFFIRM-35

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jul 19, 2018
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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