A multicenter, open label study to assess the safety and efficacy of risankizumab for maintenance in moderate to severe plaque type psoriasis

A multicenter, open Label study to assess the safety and efficacy of rIsankizuMab for MaInTenance in moderate to severe pLaquE type pSoriaSis (LIMMITLESS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003046-87-BE

Enrollment

2200

Registered

2016-12-22

Start date

2017-03-20

Completion date

Unknown

Last updated

2024-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Skyrizi Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Curre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects with moderate to severe chronic plaque psoriasis who have completed one of the preceding studies 1311.3, 1311.4, 1311.13, 1311.28, 1311.30, 1311.38 and M16-178. 2. Subjects must be candidates for prolonged open label risankizumab treatment according to investigator judgment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: 1. Premature discontinuation for any reason in the preceding study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of Study M15-997 is to investigate long-term safety and tolerability of risankizumab in subjects with psoriasis who have completed one of the preceding Phase 2/3 studies. ;Secondary Objective: The secondary objective of Study M15-997 is to investigate the long-term efficacy of risankizumab in the treatment of psoriasis.;Primary end point(s): Achievement of PASI 90;Timepoint(s) of evaluation of this end point: Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 132, Week 144, Week 156, Week 180, Week 204, Week 228, Week 252, End of Observation visit	—

Measure

Time frame

Main Objective: The primary objective of Study M15-997 is to investigate long-term safety and tolerability of risankizumab in subjects with psoriasis who have completed one of the preceding Phase 2/3 studies. ;Secondary Objective: The secondary objective of Study M15-997 is to investigate the long-term efficacy of risankizumab in the treatment of psoriasis.;Primary end point(s): Achievement of PASI 90;Timepoint(s) of evaluation of this end point: Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 132, Week 144, Week 156, Week 180, Week 204, Week 228, Week 252, End of Observation visit

—

Secondary

Measure	Time frame
Secondary end point(s): Achievement of PASI 75 or 100 and achievement of sPGA score of clear or almost clear;Timepoint(s) of evaluation of this end point: Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 132, Week 144, Week 156, Week 180, Week 204, Week 228, Week 252, End of Observation visit	—

Countries

Australia, Austria, Belgium, Canada, Czech Republic, European Union, Finland, France, Germany, Japan, Korea, Republic of, Mexico, Poland, Portugal, Spain, Sweden, Taiwan, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

global-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026