Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : April 18, 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.

Layout table for study information
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.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Malene Jensen, PhD +46-8-59883800 malene.jensen@affibody.se

Locations
Layout table for location information
Germany
Rothhaar Studien GmbH Recruiting
Berlin, Germany, 10783
Contact: Alex Rothhaar, Dr    +49 30 2005 1448 844    rothhaar@studien.rothhaar.com   
Praxis für Haut- und Geschlechtskrankheiten im Ärztehaus "Rudolf Virchow" Recruiting
Berlin, Germany, 13055
Contact: Thomas Wildfeuer, Dr    +49 (0) 30 9715208    Hautarztpraxis-Dr.Wildfeuer@gmx.de   
Hautzentrum Weissensee Recruiting
Berlin, Germany, 13086
Contact: Christian Kors, Dr    +49 (0)30 343470716    kors@hautzentrum-weissensee.de   
Hautarztzentrum Tegel Recruiting
Berlin, Germany, 13507
Contact: Martin Miehe    +49 (0) 30 434 50 25    miehe@derma-berlin.de   
Klinik für Dermatologie, Venerologie und Allergologie der Ruhr-Universität Recruiting
Bochum, Germany, 44791
Contact: Thilo Gambichler, Prof.    +49 (0) 0234 5093458    t.gambichler@klinikum-bochum.de   
Hautarztpraxis im Jahrhunderthaus Recruiting
Bochum, Germany, 44793
Contact: Johannes Niesmann, Dr.    +49 (0) 234 64087105    johannes.niesmann@rub.de   
RuhrDerm - Studienzentrum der Gemeinschaftspraxis für Dermatologie, Venerologie, Allergologie, Phlebologie Recruiting
Bochum, Germany, 44803
Contact: Michael Ardabili, Dr    +49 (0) 234 93451360    m.ardabili@derma.de   
Elbe Kliniken Buxtehude Recruiting
Buxtehude, Germany, 21615
Contact: Andreas Kleinheinz, Dr    +49 (0) 4161 703 6005    Andreas.Kleinheinz@Elbekliniken.de   
Rosenpark Research Recruiting
Darmstadt, Germany, 64283
Contact: Oliver Weirich, MD    +49 (0) 6151 627070    Oliver.weirich@rosenparkklinik.de   
Privatpraxis Dr. Hilton & Partner Recruiting
Düsseldorf, Germany, 40212
Contact: Rodrigo da Mota, Dr.    +49 (0)211 862 928 13    r.mota@dr-hilton.de   
Derma-Study-Center FN GmbH Recruiting
Friedrichshafen, Germany, 88045
Contact: Peter Radny, Dr.    +49 (0) 7541 26061    calvin32@gmx.de   
Contact       DSC.fn@gmx.de   
SCIderm Clinics Recruiting
Hamburg, Germany, 20354
Contact: Kristian Reich, Prof.    +49 (0) 40 55 44 01- 0    kreich@jerucon.com   
Klinik für Dermatologie, Venerologie und Allergologie Recruiting
Kiel, Germany, 24105
Contact: Sascha Gerdes, Dr. med    +49 (0) 431 500 21206    sgerdes@dermatology.uni-kiel.de   
Dermatologische Gemeinschaftspraxis Recruiting
Mahlow, Germany, 15831
Contact: Michael Sebastian, Dr.    +49 (0)3379 394 23    dr.sebastian@hautarztpraxis-mahlow.de   
Clinical research center (CRC) Department of Dermatology Recruiting
Mainz, Germany, 55131
Contact: Petra Staubach    +49 (0) 6131 175 244    petra.staubach@unimedizin-mainz.de   
Dres. Unnewehr Recruiting
Osnabrück, Germany, 49078
Contact: Thomas Rosenbach, PD.Dr.    +49 (0)541 335 000    rosenbach@ihrehautaerzte.de   
CMS³ - Company for Medical Study & Service Selters UG Recruiting
Selters, Germany, 56242
Contact: Ralph von Kiedrowski    +49 (0) 2626 900 775    dr.vonkiedrowski@cmss-selters.de   
CentroDerm GmbH Recruiting
Wuppertal, Germany, 42287
Contact: Thomas Dirschka, Professor    + 49 (0) 202 698 6173    t.dirschka@centroderm.de   
Sponsors and Collaborators
Affibody
TFS Trial Form Support
Investigators
Layout table for investigator information
Principal Investigator: Sascha Gerdes, Dr. med Klinik für Dermatologie, Venerologie und Allergologie

Layout table for additonal information
Responsible Party: Affibody
ClinicalTrials.gov Identifier: NCT03591887     History of Changes
Other Study ID Numbers: ABY-035-002
2017-001615-36 ( EudraCT Number )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases