Trial record 1 of 1 for:
NCT03635099
This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03635099 |
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Recruitment Status :
Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : May 4, 2021
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Brief Summary:
The primary objective is based on Week 12 co-primary endpoints of PASI (Psoriasis Area and Severity Index) 75 and sPGA (Static Physician's Global Assessment) 0/1, and overall safety Secondary objectives of Part 1 are to evaluate the efficacy and safety of BI 730357 through 24 weeks of treatment
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis | Drug: BI 730357 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 274 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis |
| Actual Study Start Date : | September 17, 2018 |
| Estimated Primary Completion Date : | May 7, 2021 |
| Estimated Study Completion Date : | June 4, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dose group A |
Drug: BI 730357
Film-coated tablet |
| Experimental: Dose group B |
Drug: BI 730357
Film-coated tablet |
| Experimental: Dose group C |
Drug: BI 730357
Film-coated tablet |
| Experimental: Dose group D |
Drug: BI 730357
Film-coated tablet |
| Placebo Comparator: Placebo |
Drug: Placebo
Film-coated tablet |
| Experimental: Dose group V |
Drug: BI 730357
Film-coated tablet |
| Experimental: Dose group U |
Drug: BI 730357
Film-coated tablet |
| Placebo Comparator: Placebo W |
Drug: Placebo
Film-coated tablet |
Primary Outcome Measures :
- Achievement of ≥ 75% reduction from baseline PASI (Psoriasis Area and Severity Index) score (PASI 75) at Week 12 [ Time Frame: Up to Week 12 ]
- Achievement of a sPGA (Static Physician's Global Assessment) score of clear or almost clear at Week 12 [ Time Frame: Up to Week 12 ]
Secondary Outcome Measures :
- Achievement of ≥50% reduction from baseline in PASI (Psoriasis Area and Severity Index) score (PASI50) at Week 12 [ Time Frame: Up to Week 12 ]
- Achievement of ≥90% reduction from baseline in PASI (Psoriasis Area and Severity Index) score (PASI90) at Week 12 [ Time Frame: Up to Week 12 ]
- Achievement of 100% reduction from baseline in PASI (Psoriasis Area and Severity Index) score (PASI100) at Week 12 [ Time Frame: Up to Week 12 ]
- Achievement of sPGA (Static Physician's Global Assessment) score of clear at Week 12 [ Time Frame: Up to Week 12 ]
- Achievement of ≥75% reduction from baseline in PASI (Psoriasis Area and Severity Index) score (PASI75) at Week 16, 20, 24 [ Time Frame: Up to Week 24 ]dose groups A to D
- Achievement of an sPGA (Static Physician's Global Assessment) score of clear or almost clear at Week 16, 20, 24 [ Time Frame: Up to Week 24 ]dose groups A to D
- Change from baseline in psoriasis symptoms evaluated using the total score on the Psoriasis Symptoms Scale (PSS) at week 12 [ Time Frame: Up to Week 12 ]
- Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 12 [ Time Frame: Up to Week 12 ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients. Woman Of Childbearing 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.
- Age 18 to 75 years (both inclusive) at screening
- BMI < 35 kg/m2 at screening
- Diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient
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Patients must be candidates for systemic PsO therapy.Moderate-to-severe plaque psoriasis:
- BSA ≥10% and
- PASI ≥12 and
- sPGA moderate or severe
- 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 or previous exposure to BI 730357.
- Current enrollment in another investigational device or drug trial, or is less than 30 days (from randomisation) since ending another investigational device or drug trial(s), or receipt of other investigational treatment(s).
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Use of
- any biologic agent within 12 weeks, or
- any anti IL-23 biologic agent within 24 weeks prior to randomisation, or
- systemic anti-psoriatic medications or phototherapy within 4 weeks prior to randomisation, or
- topical anti-psoriasis medications within 2 weeks prior to randomisation
- Receipt of a live vaccination within 12 weeks prior to randomisation (visit 2), or any plan to receive a live vaccination during the conduct of this trial
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe 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.
- Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomisation or planned within 12 months after screening, e.g., hip replacement
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, 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, candidiasis and tuberculosis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- Evidence of a current or previous disease (including known or suspected IBD, and 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 (CSSRS) in the past 3 months (i.e., active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
- Unwillingness to adhere to the rules of UV-light protection
- Further exclusion criteria apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635099
Locations
Show 34 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT03635099 |
| Other Study ID Numbers: |
1407-0030 2017-004659-21 ( EudraCT Number ) |
| First Posted: | August 17, 2018 Key Record Dates |
| Last Update Posted: | May 4, 2021 |
| Last Verified: | May 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |