Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

NCT05739435 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ESK-001-007
• Study Type: interventional
• Target: 165
• Locations: 2 countries
• Sites: 38

Brief Summary

This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of long-term ESK-001 treatment

  Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Approximately 3 years

Secondary Outcomes (3)

• To assess the long-term efficacy of ESK-001

  Approximately 3 years

• To assess the change in quality of life (QoL) with long-term ESK-001 administration

  Approximately 3 years

• To assess the pharmacokinetics (PK) of ESK-001 (ctrough)

  2 years

Study Arms (2)

envudeucitinib Dose Level 1

EXPERIMENTAL

envudeucitinib administered as an oral tablet

Drug: envudeucitinib

envudeucitinib Dose Level 2

EXPERIMENTAL

envudeucitinib administered as an oral tablet

Drug: envudeucitinib

Interventions

envudeucitinib DRUG

Oral tablet

envudeucitinib Dose Level 1; envudeucitinib Dose Level 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have completed a prior ESK-001 study
• Men and Women must use highly effective methods of contraception for the entirety of the study

You may not qualify if:

• Pregnancy
• Received a prohibited concomitant medication

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (38)

Investigator Site # 1029

Birmingham, Alabama, 35205, United States

Location

Investigator Site #1001

Phoenix, Arizona, 85032, United States

Location

Investigator Site # 1023

Rogers, Arkansas, 72758, United States

Location

Investigator Site #1021

Encinitas, California, 92024, United States

Location

Investigator Site #1018

Los Angeles, California, 90045, United States

Location

Investigator Site #1007

Santa Monica, California, 90404, United States

Location

Investigator Site #1002

Sherman Oaks, California, 91403, United States

Location

Investigator site # 1030

Fort Lauderdale, Florida, 33308, United States

Location

Investigator Site #1025

Hialeah, Florida, 33012, United States

Location

Investigator site # 1028

Miami, Florida, 33175, United States

Location

Investigator Site # 1013

Tampa, Florida, 33614, United States

Location

Investigator Site #1035

Macon, Georgia, 31217, United States

Location

Investigator Site #1043

Sandy Springs, Georgia, 30328, United States

Location

Investigator Site #1005

Rolling Meadows, Illinois, 60008, United States

Location

Investigator Site # 1011

Columbus, Indiana, 47201, United States

Location

Investigator Site #1027

South Bend, Indiana, 46617, United States

Location

Investigator SIte#1036

Overland Park, Kansas, 66210, United States

Location

Investigator Site #1017

Owensboro, Kentucky, 42301, United States

Location

Investigator Site #1026

Rockville, Maryland, 20850, United States

Location

Investigator Site #1010

Clarkston, Michigan, 48346, United States

Location

Investigator Site #1031

New Brighton, Minnesota, 55112, United States

Location

Investigator Site #1033

Norman, Oklahoma, 73071, United States

Location

Investigator Site #1019

Portland, Oregon, 97223, United States

Location

Investigator Site #1022

Philadelphia, Pennsylvania, 19103, United States

Location

Investigator Site # 1012

Rapid City, South Dakota, 57702, United States

Location

Investigator Site #1015

Houston, Texas, 77056, United States

Location

Investigator Site # 1006

San Antonio, Texas, 78213, United States

Location

Investigator Site # 1041

South Jordan, Utah, 84095, United States

Location

Investigator Site #2001

Edmonton, Alberta, T6G 1C3, Canada

Location

Investigator Site # 2008

Surrey, British Columbia, V3V 0C6, Canada

Location

Investigator Site #2003

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigator Site #2006

London, Ontario, N6H 5L5, Canada

Location

Investigator Site # 2004

Mississauga, Ontario, L4Y 4C5, Canada

Location

Investigator Site # 2007

North Bay, Ontario, PiB 3Z7, Canada

Location

Investigator Site #2005

Oakville, Ontario, L6J 7W5, Canada

Location

Investigator Site #2009

Toronto, Ontario, M3H 5Y8, Canada

Location

Investigator Site # 2002

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigator Site # 2010

Québec, Quebec, G1V 4X7, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 22, 2023
• Study Start: January 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CA (10); US (28)