LIMMITLESS

A Study to Assess the Safety and Efficacy of an Active Drug for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)

Brief summary

The purpose of this study is to investigate the long-term safety and efficacy of an active drug in the treatment of moderate to severe chronic plaque psoriasis.

Interventional study

Status:
Completed
Conditions:
Psoriasis
Enrollment:
2172 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-997
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Participants with a history of moderate to severe chronic plaque psoriasis, who have
completed one of the preceding studies.

- Participants must be candidates for prolonged open label risankizumab treatment
according to investigator judgment.

- Females of childbearing potential must have a negative urine pregnancy test result at
Baseline.

If female, participant must be either postmenopausal, OR permanently surgically sterile OR
for women of childbearing potential practicing at least one protocol specified method of
birth control, starting at Baseline through at least 20 weeks after the last dose of study
drug.

- Participants must have signed and dated a written informed consent in accordance with
Good Clinical Practice (GCP) and local legislation prior to admission into the study.

Exclusion Criteria:

- Premature discontinuation for any reason in the preceding study.

- Participants who have developed guttate, erythrodermic, pustular or drug-induced
psoriasis as diagnosed by the investigator during the preceding study.

- Use of any prohibited medication or any drug considered likely to interfere with the
safe conduct of the study, as assessed by the investigator.

- Evidence of a current or previous disease, medical condition (including chronic
alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ
transplant), medical examination finding (including vital signs and ECG), or
laboratory value outside the reference range that in the opinion of the investigator
is clinically significant and would make the study participant unreliable to adhere to
the protocol or to complete the study, compromise the safety of the subject, or
compromise the quality of the data.

- Previous enrollment in this study.

- Female subject who is pregnant, breastfeeding or is considering becoming pregnant
during the study or within 20 weeks after the last dose of study drug.

- Time elapsed is > 8 weeks since the completion visit in the preceding study.

- Participant is considered by the investigator for any reason, to be an unsuitable
candidate for the study and not able to comply with the study protocol.

All the cities where the clinical studies are located

Ajax - L1S 7K8

More information about this study

clinicaltrials.gov