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A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis (AFFIRM-35)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03591887
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
TFS Trial Form Support
Information provided by (Responsible Party):
Affibody

Brief Summary:

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 a four week screening period, three treatment periods of a total of 48 weeks, and a four-week follow-up period.

The subjects are randomized to one out of four dose levels, or placebo (1:1:1:1:1). After the first 12 weeks of treatment, the subjects randomized to placebo will receive active treatment. The dose levels and dosing intervals are adjusted depending on the absolute PASI score, to obtain an individualized treatment regimen.


Condition or disease Intervention/treatment Phase
Plaque Psoriasis Biological: ABY-035 Biological: Placebo Phase 2

Detailed Description:

The study evaluates four dose levels of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis.

The study consists of a four week screening period, three treatment periods and a four-week follow-up period.

The treatment periods are:

  1. Randomized treatment; four dose levels and placebo. Biweekly (Q2W) administration during during 12 weeks.
  2. Administration Q2W during during 12 weeks, starting with a possible dose adjustment depending on the achieved absolute PASI score. Subjects on placebo are switched to active drug every 4 weeks (Q4W).
  3. Administration Q4W, starting with a possible dose adjustment , depending on the achieved absolute PASI score. The dosing interval is varied between Q4W and Q8W, depending on the PASI score.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : January 29, 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: ABY-035 2 mg
2 mg ABY-035 SC
Biological: ABY-035
ABY-035 solution for injection

Experimental: ABY-035 20 mg
20 mg ABY-035 SC
Biological: ABY-035
ABY-035 solution for injection

Experimental: ABY-035 80 mg
80 mg ABY-035 SC
Biological: ABY-035
ABY-035 solution for injection

Experimental: ABY-035 160 mg
160 mg ABY-035 SC
Biological: ABY-035
ABY-035 solution for injection

Placebo Comparator: Placebo
Placebo, switching to 80 mg ABY-035 after 12 weeks
Biological: Placebo
Placebo to ABY-035 solution for injection




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of treatment-related Adverse Events [ Time Frame: 52 weeks ]
    Adverse Events judged by the investigator to be related to study medication

  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 ≥75% improvement in PASI (PASI75) at week 12 [ Time Frame: 12 weeks ]
    A ≥75% reduction from Baseline in PASI score

  5. 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

  6. Proportion of subjects with an absolute PASI score ≤1 at week 12 [ Time Frame: 12 weeks ]
    PASI ≤1 equals clear or almost clear skin

  7. Proportion of subjects with an absolute PASI score ≤1 at week 24 [ Time Frame: 24 weeks ]
    PASI ≤1 equals clear or almost clear skin

  8. Proportion of subjects with an absolute PASI score ≤1 at week 52 [ Time Frame: 52 weeks ]
    PASI ≤1 equals clear or almost clear skin

  9. Proportion of subjects with 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)

  10. Proportion of subjects with 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.

  11. Proportion of subjects with DLQI of 0 or 1 at week 24 [ Time Frame: Week 24 ]
    DLQI: Dermatology Life Quality Index

  12. Proportion of subjects with DLQI of 0 or 1 at week 52 [ Time Frame: Week 52 ]
    DLQI: Dermatology Life Quality Index

  13. 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.


  14. 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)

  15. 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)

  16. Pharmacokinetics: Area Under the Curve (AUC) of ABY-035 [ Time Frame: Week 12 ]
    AUC is a measure of the drug exposure

  17. Levels of anti-ABY-035 antibodies in serum [ Time Frame: Week 52 ]
    Anti-drug antibodies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or contraindication to at least two standard therapies for moderate-to-severe plaque psoriasis
  • 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 contraceptive measure, female of non-childbearing potential or sterilized male

Exclusion Criteria:

  • Current forms of psoriasis other than chronic plaque-type
  • Current drug induced psoriasis
  • 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
  • Autoimmune disease of relevance
  • Inflammatory Bowel Disease requiring treatment within the past 12 months
  • 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
  • Numerous recent previous psoriasis treatments ,with 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591887


Contacts
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Contact: Rolf Westerberg, PhD +46705415413 rolf.westerberg@affibody.se

Locations
Show Show 18 study locations
Sponsors and Collaborators
Affibody
TFS Trial Form Support
Investigators
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Principal Investigator: Sascha Gerdes, Dr. med Klinik für Dermatologie, Venerologie und Allergologie
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Responsible Party: Affibody
ClinicalTrials.gov Identifier: NCT03591887    
Other Study ID Numbers: ABY-035-002
2017-001615-36 ( EudraCT Number )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases