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NCT04713072
A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
Phase 2 trial testing ABY-035 in Psoriatic Arthritis in 129 participants. Completed in 27 January 2022.
1 October 2021
Quick facts
| Lead sponsor | ACELYRIN Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 129 |
| Start date | 4 August 2020 |
| Primary completion | 1 October 2021 |
| Estimated completion | 27 January 2022 |
| Sites | 32 locations across Belgium, Austria, Germany, Hungary, Poland, Spain, Czechia |
Drugs / interventions tested
- ABY-035 — full drug profile →
- Placebo
Conditions studied
- Psoriatic Arthritis — all drugs for Psoriatic Arthritis →
Sponsor
ACELYRIN Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis.
Klint S, Feldwisch J, Gudmundsdotter L, Dillner Bergstedt K, et al · · 2023 · cited 37× · PMID 37184136 · DOI 10.1080/19420862.2023.2209920 -
IL-23 orchestrating immune cell activation in arthritis.
Najm A, McInnes IB. · · 2021 · cited 18× · PMID 34668017 · DOI 10.1093/rheumatology/keab266 -
The Pathophysiological Significance of Dual Inhibition of IL-17A and IL-17F in Psoriatic Arthritis and Axial Spondyloarthritis.
Katsouli O, Lainis V, Goules AV, Vlachoyiannopoulos PG. · · 2026 · PMID 41648061 · DOI 10.31138/mjr.020925.aar -
Exploring the Cutting Edge: A Recap of EULAR & ACR 2023 Highlights for Spondyloarthritis, including Psoriatic Arthritis.
Gerolymatou N, Voulgari PV. · · 2024 · PMID 39974593 · DOI 10.31138/mjr.040524.aeh
Verify or expand the search:
- PubMed search for NCT04713072
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ABY-035
Trials testing the same drug.
- NCT04795141 — ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis · Phase 2 · terminated
- NCT03591887 — A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis · Phase 2 · completed
Other recruiting trials for Psoriatic Arthritis
Currently open trials in the same condition.
- NCT07286058 — Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis · Phase 3 · recruiting
- NCT07295509 — A Study of Picankibart in Patients With Active Psoriatic Arthritis · Phase 2, PHASE3 · recruiting
- NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu · Phase 1 · recruiting
- NCT07180537 — Creating Health Course Study for People With Rheumatological Conditions · NA · recruiting
- NCT06888193 — A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® · Phase 1 · recruiting
Other ACELYRIN Inc. trials
Trials by the same sponsor.
- NCT05905783 — Hidradenitis Suppurativa Study of Izokibep · Phase 3 · terminated
- NCT05683496 — Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED) · Phase 1, PHASE2 · completed
- NCT05623345 — Psoriatic Arthritis Study of Izokibep · Phase 2, PHASE3 · terminated
- NCT05384249 — Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis · Phase 2 · terminated
- NCT05355805 — Hidradenitis Suppurativa Phase 2b Study of Izokibep · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04713072 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ACELYRIN Inc.
- Last refreshed: 9 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04713072.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing