NCT05431634 is a Phase 1 clinical trial of Experimental drug: ESK-001 in Safety and Tolerability, sponsored by Alumis Inc.

Who is sponsoring NCT05431634?

NCT05431634 is sponsored by Alumis Inc.

What drugs are being tested in NCT05431634?

Interventions in NCT05431634: Experimental drug: ESK-001, Placebo.

What condition does NCT05431634 study?

NCT05431634 studies Safety and Tolerability.

Is NCT05431634 still recruiting?

NCT05431634 is currently completed. Last updated 9 May 2023.

Last reviewed 2023-05-09 · How we verify

NCT05431634

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants

Completed Phase 1 Last updated 9 May 2023

What this trial tests

Phase 1 trial testing Experimental drug: ESK-001 in Safety and Tolerability in 49 participants. Completed in 31 December 2022.

Timeline

12 May 2022

Primary endpoint
1 December 2022

31 December 2022

Quick facts

Lead sponsor	Alumis Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	49
Start date	12 May 2022
Primary completion	1 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

Experimental drug: ESK-001 — full drug profile →
Placebo

Conditions studied

Safety and Tolerability — all drugs for Safety and Tolerability →

Sponsor

Alumis Inc — full company profile →

Who can join

Adults 18 to 60, any sex, with Safety and Tolerability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy Participants

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Oral Therapies for the Treatment of Psoriasis: A Review of Pipeline Agents.
Drakos A, Torres T, Vender R. · · 2024 · cited 21× · PMID 38258121 · DOI 10.3390/pharmaceutics16010111
Safety, tolerability, pharmacokinetics, and pharmacodynamics of the oral allosteric TYK2 inhibitor ESK-001 using a randomized, double-blind, placebo-controlled study design.
Ucpinar S, Kwan JK, Hoffman JD, Tilley MK, et al · · 2024 · cited 10× · PMID 39604226 · DOI 10.1111/cts.70094
Envudeucitinib, a Potent, Next-Generation, Allosteric Inhibitor of TYK2: A Narrative Review.
Armstrong AW, Krueger JG, Strober BE, Stein Gold LF, et al · · 2026 · PMID 41934538 · DOI 10.1007/s13555-026-01727-9

Verify or expand the search:

Other recruiting trials for Safety and Tolerability

Currently open trials in the same condition.

NCT07098663 — Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes · Phase 2 · recruiting

Other Alumis Inc trials

Trials by the same sponsor.

NCT06962774 — An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and · Phase 1 · completed
NCT06588738 — A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 · Phase 3 · completed
NCT06586112 — A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis · Phase 3 · completed
NCT07378579 — An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001 · Phase 1 · completed
NCT07442149 — An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05431634 (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 Alumis Inc
Last refreshed: 9 May 2023

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/NCT05431634.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing