A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT03835481

Collaborator

(none)

165

Enrollment

Locations

Arms

28.3

Actual Duration (Months)

5.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: BI 730357 Drug: Placebo to match BI 730357	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

165 participants

Allocation:

N/A

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis

Actual Study Start Date :

Mar 18, 2019

Actual Primary Completion Date :

Jun 22, 2021

Actual Study Completion Date :

Jul 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Blinded period of Placebo until Week 12	Drug: Placebo to match BI 730357 Film-coated tablet
Experimental: BI 730357 Fasted Condition Blinded period of BI 730357 until Week 12 (4 dose levels or placebo as continued from trial 1407-0030). Open label period of BI30357 from Week 12 to end of trial (2 dose levels).	Drug: BI 730357 Film-coated tablet
Experimental: BI 730357 Fed Condition Patients entering extension trial from Part 2 of trial 1407-0030	Drug: BI 730357 Film-coated tablet

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Blinded period of Placebo until Week 12

Drug: Placebo to match BI 730357

Film-coated tablet

Experimental: BI 730357 Fasted Condition

Blinded period of BI 730357 until Week 12 (4 dose levels or placebo as continued from trial 1407-0030). Open label period of BI30357 from Week 12 to end of trial (2 dose levels).

Drug: BI 730357

Film-coated tablet

Experimental: BI 730357 Fed Condition

Patients entering extension trial from Part 2 of trial 1407-0030

Drug: BI 730357

Film-coated tablet

Outcome Measures

Primary Outcome Measures

The occurence of treatment emergent adverse events (TEAEs) [Up to Week 288]

Secondary Outcome Measures

Achievement of Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 [Up to Week 24]
Achievement of Static Physician's Global Assessment (sPGA) score 0 (clear) or 1 (almost clear) [Up to Week 24]
Achievement of sPGA score 0 (clear) [Up to Week 24]
Time to loss of PASI50/PASI75/PASI90/PASI100 for patients who achieve the response [Up to Week 288]
Time to loss of sPGA clear or almost clear for patients who achieve the response [Up to Week 288]
Time to loss of sPGA clear for patients who achieve the response [Up to Week 288]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Woman Of Child Bearing Potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and
for patients entering from Part 1 of trial 1407-0030

--- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit

for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or perceived patient improvement, at the discretion of the Investigator
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria:

Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations.
Previous enrolment in this trial.
Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
Any plan to receive a live vaccination during the conduct of the trial.
Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Any documented active or suspected malignancy, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
Relevant chronic or acute infections including human immunodeficiency virus (HIV), viral hepatitis and tuberculosis.
Evidence of a disease (including known or suspected IBD, cardiovascular disease), or medical finding 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 trial, compromise the safety of the patient, or compromise the quality of the data.
Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 12 months (i.e., active suicidal thought with intent but without specific plan), or active suicidal thought with plan and intent in the past.
Unwillingness to adhere to the rules of UV-light protection
Ongoing AEs consistent with intolerance of trial medication (including gastric intolerance) from 1407-0030, that in the opinion of the investigator would compromise the safety of the patient.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama	United States	35205
2	Dermatology Research Associates	Los Angeles	California	United States	90045
3	Southern California Dermatology Inc.	Santa Ana	California	United States	92701
4	Hamilton Research	Alpharetta	Georgia	United States	30022
5	Advanced Medical Research PC	Sandy Springs	Georgia	United States	30328
6	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46250
7	The Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey	United States	08520
8	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10003
9	Clinical Partners, LLC	Johnston	Rhode Island	United States	02919
10	Clinical Research Center of the Carolinas	Charleston	South Carolina	United States	29407
11	Health Concepts	Rapid City	South Dakota	United States	57702
12	Menter Dermatology Research Institute	Dallas	Texas	United States	75246
13	Center for Clinical Studies	Houston	Texas	United States	77004
14	Center for Clinical Studies	Webster	Texas	United States	77598
15	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502
16	Dr Chih-ho Hong Medical Inc	Surrey	British Columbia	Canada	V3R 6A7
17	Enverus Medical Research	Surrey	British Columbia	Canada	V3V 0C6
18	Dr. Irina Turchin PC Inc.	Fredericton	New Brunswick	Canada	E3B 1G9
19	The Guenther Dermatology Research Centre	London	Ontario	Canada	N6A 3H7
20	DermEdge Research Inc.	Mississauga	Ontario	Canada	L5H 1G9
21	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B 3Z7
22	The Centre for Clinical Trials	Oakville	Ontario	Canada	L6J 7W5
23	SKiN Centre for Dermatology	Peterborough	Ontario	Canada	K9J 5K2
24	K. Papp Clinical Research Inc.	Waterloo	Ontario	Canada	N2J 1C4
25	XLR8 Medical Research Inc.	Windsor	Ontario	Canada	N8W 1E6
26	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117
27	Universitätsklinikum Frankfurt	Frankfurt am Main		Germany	60596
28	TFS Trial Form Support GmbH	Hamburg		Germany	20537
29	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck		Germany	23538
30	Universitätsklinikum Münster	Münster		Germany	48149

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT03835481

Other Study ID Numbers:

1407-0005
2018-003487-31

First Posted:

Feb 8, 2019

Last Update Posted:

Aug 3, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of Aug 3, 2021