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NCT03580278
A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2
Phase 1 trial testing ABY-035/AFO2 in Psoriasis in 33 participants. Completed in 22 September 2020.
22 September 2020
Quick facts
| Lead sponsor | Affibody |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 13 November 2019 |
| Primary completion | 22 September 2020 |
| Estimated completion | 22 September 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ABY-035/AFO2 — full drug profile →
Conditions studied
- Psoriasis — all drugs for Psoriasis →
Sponsor
Affibody — full company profile →
Who can join
Adults 18 to 70, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this first-in-human study of the formulation ABY-035/AFO2 is to investigate the safety, tolerability and efficacy after multiple doses in sequential escalating dose cohorts in psoriasis subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03580278
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
- NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
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Other Affibody trials
Trials by the same sponsor.
- NCT07081555 — A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breas · Phase 1 · recruiting
- NCT03591887 — A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis · Phase 2 · completed
- NCT03502954 — A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-039 · Phase 1 · terminated
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 NCT03580278 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Affibody
- Last refreshed: 25 January 2022
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/NCT03580278.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing