Psoriatic ArthritisPhase 2NCT04713072
A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
A Phase 2 study testing ABY-035 in people with Psoriatic Arthritis, run by ACELYRIN Inc. at 32 sites in 7 countries.
Trial summary
This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- 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
- 129 participants
- Where
- 32 sitesin 7 countries
- Study dates
- 4 Aug 2020to 27 Jan 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has given his / her signed declaration of consent and data protection declaration
- At least 18 years and less than 75 years of age at Screening visit
- Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
- Active psoriatic arthritis defined by:
- ≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
- ≥3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit
Show all 9Show fewer
- Precedent failure or insufficient treatment response to or contraindication or intolerability to nonsteroidal anti-inflammatory drug (NSAID), csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A), and/or TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab)
- Rheumatoid factor (RF) and anti-CCP antibody negative
- Presence or history of plaque psoriasis
Who cannot join
- Underlying conditions which significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
- History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
- History of or current fibromyalgia or pain syndrome
- Uncontrolled inflammatory bowel disease
- Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit
- Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
Show all 9Show fewer
- History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
- Insufficiently controlled heart failure
- Current uncontrolled arterial hyper- or hypotension
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
Germany7 sites
Rheumatologische Schwerpunktpraxis
Berlin, 12161
Schlosspark Klinik
Berlin, 14059
Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie
Frankfurt, 60590
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Rheumazentrum Ruhrgebiet Herne
Herne, 79106
Klinikum der Universität München Rheumatologie
München, 80336
Rheumazentrum Ratingen
Ratingen, 40878
Poland7 sites
Nasz Lekarz Ośrodek Badań Klinicznych
Bydgoszcz, 85-065
PRATIA MCM Krakow
Krakow, 30-510
Centrum Medyczne AMED oddział w Łodzi
Lodz, 91-363
ETYKA Ośrodek Badań Klinicznych
Olsztyn, 10-117
ETG Skierniewice
Skierniewice, 96-100
ETG Warszawa
Warsaw, 02-793
Centrum Medyczne AMED
Warsaw, 03-291
Spain6 sites
Complejo Hospitalario Universitario de A Coruña
A Coruña, 15006
Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC
Córdoba, 14004
Cliníca Ceta - Unidad de Ensayos Clínicos
Madrid, 28915
Hospital Parc Tauli de Sabadell
Sabadell, 8208
Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario
Santiago de Compostela, 15706
Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología
Seville, 41011
Czechia4 sites
VESALION s.r.o.
Ostrava, 702 00
Revmatologický ústav
Prague, 128 00
MEDICAL PLUS s.r.o.
Uherské Hradiště
PV Medical Services s.r.o.
Zlín, 760 01
Hungary4 sites
Qualiclinic Kft.
Budapest, 1036
CRU Hungary Ltd
Miskolc, 3529
MÁV Kórház és Rendelőintézet, Reumtólegia
Szolnok, 5000
Vital Medical Center
Veszprém, 8200
Austria3 sites
LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie
Graz, 8036
Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II
Innsbruck, 6020
Vienna Medical University Department of Internal Medicine III Division of Rheumatology
Vienna, 1090
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Clinical Trial in Patients With Active Psoriatic Arthritis to Investigate Efficacy, Tolerability, Safety, Pharmacokinetics and Immunogenicity of ABY-035
This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA.
Read the detailed description
The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit) comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of follow-up.
Treatment Periods are:
- Treatment Period I: from V1 (Week 0) to V9 (Week 16)
- Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing)
At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal rates (1:1:1) to one of three parallel groups (A, B, C).
The treatment will be administered once every 2 weeks (Q2W).
Patients assigned to groups A and B will receive active treatment from V1 to V16 (group A = 40 mg ABY-035; group B = 80 mg ABY-035). Patients initially assigned to placebo will switch to active treatment at visit V9 in a blinded fashion (group C = Placebo from V1 to V8 and 80 mg ABY-035 from V9 to V16).
- Conditions
- Psoriatic Arthritis
- Being tested
- ABY-035, Placebo
- Medical subject headings
- Arthritis, Psoriatic
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 40 mg | Experimental | 40 mg ABY-035 SC Receives: Biological: ABY-035 |
| ABY-035 80 mg | Experimental | 80 mg ABY-035 SC Receives: Biological: ABY-035 |
| Placebo | Placebo comparator | Placebo, switching to 80 mg ABY-035 after 16 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 50 response rate (ACR50)
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
Measured: 16 weeks
ACR50
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
Measured: 12 weeks
Secondary outcomes (5)
ACR20/70
ACR20/70 response rate, percentage of patients achieving Minimal Disease Activity (MDA): at V9 (Week 16) for higher Dose vs. Placebo
Measured: 16 weeks
ACR20/70
ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo
Measured: 12 weeks
ACR20/50/70
ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo
Measured: 16 weeks
ACR20/50/70
ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo
Measured: 12 weeks
ACR 20/50/70
ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start4 Aug 2020
- Primary completion1 Oct 2021
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACELYRIN Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myreen Tomas, MD, Study director, ACELYRIN Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713072
- Sponsor's protocol ID
- ABY-035-202
- Status last verified
- Nov 2022
- First submitted
- 14 Jan 2021
- Last updated
- 9 Feb 2024
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Clinical Trial in Patients With Active Psoriatic Arthritis to Investigate Efficacy, Tolerability, Safety, Pharmacokinetics and Immunogenicity of ABY-035
- ClinicalTrials.gov ID
- NCT04713072
- Acronym / sponsor ID
- ABY-035-202
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- ACELYRIN Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 19 Jan 2021 (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 is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA.
Detailed description
The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit) comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of follow-up.
Treatment Periods are:
- Treatment Period I: from V1 (Week 0) to V9 (Week 16)
- Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing)
At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal rates (1:1:1) to one of three parallel groups (A, B, C).
The treatment will be administered once every 2 weeks (Q2W).
Patients assigned to groups A and B will receive active treatment from V1 to V16 (group A = 40 mg ABY-035; group B = 80 mg ABY-035). Patients initially assigned to placebo will switch to active treatment at visit V9 in a blinded fashion (group C = Placebo from V1 to V8 and 80 mg ABY-035 from V9 to V16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABY-035 40 mg | Experimental | Biological: ABY-03540 mg ABY-035 SC |
| ABY-035 80 mg | Experimental | Biological: ABY-03580 mg ABY-035 SC |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo, switching to 80 mg ABY-035 after 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient who has given his / her signed declaration of consent and data protection declaration
- At least 18 years and less than 75 years of age at Screening visit
- Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
- Active psoriatic arthritis defined by:
- ≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
Key exclusion criteria (9 listed)
- Underlying conditions which significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
- History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
- History of or current fibromyalgia or pain syndrome
- Uncontrolled inflammatory bowel disease
- Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit
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 40 mg, ABY-035 80 mg |
| PlaceboPlacebo to ABY-035 solution for injection | Biological | Placebo |
Primary outcome
American College of Rheumatology 50 response rate (ACR50)
Time frame: 16 weeks
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
ACR50
Time frame: 12 weeks
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
5 secondary outcomes
ACR20/70
Time frame: 16 weeks
ACR20/70
Time frame: 12 weeks
ACR20/50/70
Time frame: 16 weeks
ACR20/50/70
Time frame: 12 weeks
ACR 20/50/70
Time frame: 8 weeks
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 9 Feb 2024.
- 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.
Myreen Tomas, MD study director
ACELYRIN Inc.
32 sites in 7 countries: 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 Psoriatic Arthritis, run by ACELYRIN Inc. at 32 sites in 7 countries.
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 9 inclusion and 9 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 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Germany, Poland, Spain, Czechia, Hungary and 2 more countries. 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?
American College of Rheumatology 50 response rate (ACR50) (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 9 Feb 2024.