Plaque PsoriasisPhase 2AFFIRM-35NCT03591887
A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis
A Phase 2 study testing ABY-035 in people with Plaque Psoriasis, run by Affibody at 18 sites in Germany.
Trial 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 52-week Core study and two optional 52-week periods, Extension and Prolongation of Extension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ABY-035
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 18 sitesGermany
- Study dates
- 7 Mar 2018to 3 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites
Rothhaar Studien GmbH
Berlin, 10783
Praxis für Haut- und Geschlechtskrankheiten im Ärztehaus "Rudolf Virchow"
Berlin, 13055
Hautzentrum Weissensee
Berlin, 13086
Hautarztzentrum Tegel
Berlin, 13507
Klinik für Dermatologie, Venerologie und Allergologie der Ruhr-Universität
Bochum, 44791
Hautarztpraxis im Jahrhunderthaus
Bochum, 44793
RuhrDerm - Studienzentrum der Gemeinschaftspraxis für Dermatologie, Venerologie, Allergologie, Phlebologie
Bochum, 44803
Elbe Kliniken Buxtehude
Buxtehude, 21615
Rosenpark Research
Darmstadt, 64283
Privatpraxis Dr. Hilton & Partner
Düsseldorf, 40212
Derma-Study-Center FN GmbH
Friedrichshafen, 88045
SCIderm Clinics
Hamburg, 20354
Klinik für Dermatologie, Venerologie und Allergologie
Kiel, 24105
Dermatologische Gemeinschaftspraxis
Mahlow, 15831
Clinical research center (CRC) Department of Dermatology
Mainz, 55131
Dres. Unnewehr
Osnabrück, 49078
CMS³ - Company for Medical Study & Service Selters UG
Selters, 56242
CentroDerm GmbH
Wuppertal, 42287
About this study
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
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).
Read the detailed description
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.
- Conditions
- Plaque Psoriasis
- Being tested
- ABY-035, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABY-035Biological
ABY-035 solution for injection
PlaceboBiological
Placebo to ABY-035 solution for injection
| Study group | Role | What they receive |
|---|---|---|
| ABY-035 2 mg | Experimental | 2 mg ABY-035 SC Receives: Biological: ABY-035 |
| ABY-035 20 mg | Experimental | 20 mg ABY-035 SC Receives: Biological: ABY-035 |
| ABY-035 80 mg | Experimental | 80 mg ABY-035 SC Receives: Biological: ABY-035 |
| ABY-035 160 mg | Experimental | 160 mg ABY-035 SC Receives: Biological: ABY-035 |
| Placebo | Placebo comparator | Placebo, switching to 80 mg ABY-035 after 12 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (88)
Number of treatment emergent Adverse Events
Adverse Events starting after first administration of study drug
Measured: 52 weeks
Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 24
A ≥90% reduction from Baseline in PASI score
Measured: 24 weeks
Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 52
A ≥90% reduction from Baseline in PASI score
Measured: 52 weeks
Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 12
A ≥50% reduction from Baseline in PASI score
Measured: 12 weeks
Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 24
A ≥50% reduction from Baseline in PASI score
Measured: 24 weeks
Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 52
A ≥50% reduction from Baseline in PASI score
Measured: 52 weeks
Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 12
A ≥75% reduction from Baseline in PASI score
Measured: 12 weeks
Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 24
A ≥75% reduction from Baseline in PASI score
Measured: 24 weeks
Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 52
A ≥75% reduction from Baseline in PASI score
Measured: 52 weeks
Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 12
A 100% reduction from Baseline in PASI score
Measured: 12 weeks
Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 24
A 100% reduction from Baseline in PASI score
Measured: 24 weeks
Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 52
A 100% reduction from Baseline in PASI score
Measured: 52 weeks
Change from baseline in PASI score at week 12
PASI: Psoriasis Area and Severity Index
Measured: Week 12
Change from baseline in PASI score at week 24
PASI: Psoriasis Area and Severity Index
Measured: Week 24
Change from baseline in PASI score at week 52
PASI: Psoriasis Area and Severity Index
Measured: Week 52
Proportion of subjects achieving an absolute PASI score ≤1 at week 12
PASI ≤1 equals clear or almost clear skin
Measured: 12 weeks
Proportion of subjects achieving an absolute PASI score ≤1 at week 24
PASI ≤1 equals clear or almost clear skin
Measured: 24 weeks
Proportion of subjects achieving an absolute PASI score ≤1 at week 52
PASI ≤1 equals clear or almost clear skin
Measured: 52 weeks
Proportion of subjects achieving an absolute PASI score <3 at week 12
PASI: Psoriasis Area and Severity Index
Measured: 12 weeks
Proportion of subjects achieving an absolute PASI score <3 at week 24
PASI: Psoriasis Area and Severity Index
Measured: 24 weeks
Proportion of subjects achieving an absolute PASI score <3 at week 52
PASI: Psoriasis Area and Severity Index
Measured: 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)
Measured: 12 weeks
Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 24
sPGA: Static Physician's Global Assessment
Measured: 24 weeks
Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 52
sPGA: Static Physician's Global Assessment
Measured: 52 weeks
Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 12
sPGA: Static Physician's Global Assessment
Measured: 12 weeks
Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 24
sPGA: Static Physician's Global Assessment
Measured: 24 weeks
Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 52
sPGA: Static Physician's Global Assessment
Measured: 52 weeks
Change from baseline in sPGA at week 12
sPGA: Static Physician's Global Assessment
Measured: 12 weeks
Change from baseline in sPGA at week 24
sPGA: Static Physician's Global Assessment
Measured: 24 weeks
Change from baseline in sPGA at week 52
sPGA: Static Physician's Global Assessment
Measured: 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.
Measured: Week 12
Change from baseline in target nail NAPSI at week 24
NAPSI: Nail Psoriasis Severity Index
Measured: Week 24
Change from baseline in target nail NAPSI at week 52
NAPSI: Nail Psoriasis Severity Index
Measured: 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.
Measured: Week 12
Proportion of subjects achieving DLQI of 0 or 1 at week 24
DLQI: Dermatology Life Quality Index
Measured: Week 24
Proportion of subjects achieving DLQI of 0 or 1 at week 52
DLQI: Dermatology Life Quality Index
Measured: Week 52
Proportion of subjects achieving DLQI of ≤ 5 at Week 12
DLQI: Dermatology Life Quality Index
Measured: Week 12
Proportion of subjects achieving DLQI of ≤ 5 at Week 24
DLQI: Dermatology Life Quality Index
Measured: Week 24
Proportion of subjects achieving DLQI of ≤ 5 at Week 52
DLQI: Dermatology Life Quality Index
Measured: Week 52
Change from baseline in DLQI at week 12
DLQI: Dermatology Life Quality Index
Measured: Week 12
DLQI at week 24 compared to baseline
DLQI: Dermatology Life Quality Index
Measured: Week 24
DLQI at week 52 compared to baseline
DLQI: Dermatology Life Quality Index
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Week 52
Pharmacokinetics: Area Under the Curve (AUC) of ABY-035
AUC is a measure of the drug exposure
Measured: 52 weeks
Levels of anti-ABY-035 antibodies in serum
Anti-drug antibodies
Measured: 52 weeks
Number of treatment emerging Adverse Events during the Extension period
Adverse Events starting after first administration of study drug
Measured: 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
Measured: 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
Measured: 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
Measured: Week 104 to Week 156
Levels of anti-ABY-035 antibodies in serum during the Extension period
Anti-drug antibodies
Measured: Week 52 to Week 104
Levels of anti-ABY-035 antibodies in serum during the Prolongation of Extension period
Anti-drug antibodies
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 156
Change from baseline in PASI score at end of Extension period
PASI: Psoriasis Area and Severity Index
Measured: Week 104
Change from baseline in PASI score at end of Prolongation of Extension period
PASI: Psoriasis Area and Severity Index
Measured: Week 156
Proportion of subjects achieving an absolute PASI score ≤1 at end of Extension period
PASI ≤1 equals clear or almost clear skin
Measured: 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
Measured: Week 156
Proportion of subjects achieving an absolute PASI score <3 at end of Extension period
PASI: Psoriasis Area and Severity Index
Measured: Week 104
Proportion of subjects achieving an absolute PASI score <3 at end of Prolongation of Extension period
PASI: Psoriasis Area and Severity Index
Measured: Week 156
Proportion of subjects achieving sPGA of 0 or 1 at end of Extension period
sPGA: Static Physician's Global Assessment
Measured: Week 104
Proportion of subjects achieving sPGA of 0 or 1 at end of Prolongation of Extension period
sPGA: Static Physician's Global Assessment
Measured: Week 156
Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at end of Extension period
sPGA: Static Physician's Global Assessment
Measured: 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
Measured: Week 156
Change from baseline in sPGA at end of Extension period
sPGA: Static Physician's Global Assessment
Measured: Week 104
Change from baseline in sPGA at end of Prolongation Extension period
sPGA: Static Physician's Global Assessment
Measured: Week 156
Change from baseline in target nail NAPSI at end of Extension period
NAPSI: Nail Psoriasis Severity Index
Measured: Week 104
Change from baseline in target nail NAPSI at end of Prolongation of Extension period
NAPSI: Nail Psoriasis Severity Index
Measured: Week 156
Proportion of subjects achieving DLQI of 0 or 1 at end of Extension period
DLQI: Dermatology Life Quality Index
Measured: Week 104
Proportion of subjects achieving DLQI of 0 or 1 at end of Prolongation of Extension period
DLQI: Dermatology Life Quality Index
Measured: Week 156
Proportion of subjects achieving DLQI of ≤ 5 at end of Extension period
DLQI: Dermatology Life Quality Index
Measured: Week 104
Proportion of subjects achieving DLQI of ≤ 5 at end of Prolongation of Extension period
DLQI: Dermatology Life Quality Index
Measured: Week 156
DLQI at end of Extension period compared to baseline
DLQI: Dermatology Life Quality Index
Measured: Week 104
DLQI at end of Prolongation of Extension period compared to baseline
DLQI: Dermatology Life Quality Index
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Week 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start7 Mar 2018
- Primary completion27 Mar 2019
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affibody
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Responsible party
- Sponsor
- Investigators
- Sascha Gerdes, Dr. med, Principal investigator, Klinik für Dermatologie, Venerologie und Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591887
- Sponsor's protocol ID
- ABY-035-002
- Other IDs
- 2017-001615-36, 2017
- Acronym
- AFFIRM-35
- Status last verified
- May 2023
- First submitted
- 1 Jun 2018
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03591887
- Acronym / sponsor ID
- AFFIRM-35 / ABY-035-002
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AffibodyIndustry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ABY-035 2 mg | Experimental | Biological: ABY-0352 mg ABY-035 SC |
| ABY-035 20 mg | Experimental | Biological: ABY-03520 mg ABY-035 SC |
| ABY-035 80 mg | Experimental | Biological: ABY-03580 mg ABY-035 SC |
| ABY-035 160 mg | Experimental | Biological: ABY-035160 mg ABY-035 SC |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo, switching to 80 mg ABY-035 after 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Use of highly effective method of contraception or female of non-childbearing potential
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABY-035ABY-035 solution for injection | Biological | ABY-035 160 mg, ABY-035 2 mg, ABY-035 20 mg, ABY-035 80 mg |
| PlaceboPlacebo to ABY-035 solution for injection | Biological | Placebo |
Primary outcome
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
88 secondary outcomes
Number of treatment emergent Adverse Events
Time frame: 52 weeks
Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 24
Time frame: 24 weeks
Proportion of subjects achieving a ≥90% improvement in PASI (PASI90) at week 52
Time frame: 52 weeks
Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 12
Time frame: 12 weeks
Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 24
Time frame: 24 weeks
Proportion of subjects achieving a ≥50% improvement in PASI (PASI50) at week 52
Time frame: 52 weeks
Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 12
Time frame: 12 weeks
Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 24
Time frame: 24 weeks
Proportion of subjects achieving a ≥75% improvement in PASI (PASI75) at week 52
Time frame: 52 weeks
Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 12
Time frame: 12 weeks
Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 24
Time frame: 24 weeks
Proportion of subjects achieving a 100% improvement in PASI (PASI100) at week 52
Time frame: 52 weeks
Change from baseline in PASI score at week 12
Time frame: Week 12
Change from baseline in PASI score at week 24
Time frame: Week 24
Change from baseline in PASI score at week 52
Time frame: Week 52
Proportion of subjects achieving an absolute PASI score ≤1 at week 12
Time frame: 12 weeks
Proportion of subjects achieving an absolute PASI score ≤1 at week 24
Time frame: 24 weeks
Proportion of subjects achieving an absolute PASI score ≤1 at week 52
Time frame: 52 weeks
Proportion of subjects achieving an absolute PASI score <3 at week 12
Time frame: 12 weeks
Proportion of subjects achieving an absolute PASI score <3 at week 24
Time frame: 24 weeks
Proportion of subjects achieving an absolute PASI score <3 at week 52
Time frame: 52 weeks
Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 12
Time frame: 12 weeks
Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 24
Time frame: 24 weeks
Proportion of subjects achieving Static Physician's Global Assessment (sPGA) 1 or 0 at week 52
Time frame: 52 weeks
Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 12
Time frame: 12 weeks
Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 24
Time frame: 24 weeks
Proportion of subjects achieving ≥2 point improvement from baseline in sPGA at week 52
Time frame: 52 weeks
Change from baseline in sPGA at week 12
Time frame: 12 weeks
Change from baseline in sPGA at week 24
Time frame: 24 weeks
Change from baseline in sPGA at week 52
Time frame: 52 weeks
Change from baseline in target nail Nail Psoriasis Severity Index (NAPSI) at week 12
Time frame: Week 12
Change from baseline in target nail NAPSI at week 24
Time frame: Week 24
Change from baseline in target nail NAPSI at week 52
Time frame: Week 52
Proportion of subjects achieving Dermatology Life Quality Index (DLQI) of 0 or 1 at week 12
Time frame: Week 12
Proportion of subjects achieving DLQI of 0 or 1 at week 24
Time frame: Week 24
Proportion of subjects achieving DLQI of 0 or 1 at week 52
Time frame: Week 52
Proportion of subjects achieving DLQI of ≤ 5 at Week 12
Time frame: Week 12
Proportion of subjects achieving DLQI of ≤ 5 at Week 24
Time frame: Week 24
Proportion of subjects achieving DLQI of ≤ 5 at Week 52
Time frame: Week 52
Change from baseline in DLQI at week 12
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha Gerdes, Dr. med principal investigator
Klinik für Dermatologie, Venerologie und Allergologie
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABY-035 in people with Plaque Psoriasis, run by Affibody at 18 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a ≥90% improvement in Psoriasis Area and Severity Index (PASI90) at week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.