BI655130 Single Dose in Generalized Pustular Psoriasis

• ClinicalTrials.gov Identifier: NCT02978690
• Recruitment Status: Completed
• First Posted: December 1, 2016
• Last Update Posted: January 17, 2018
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

This is a phase I, open label, single group study that is being performed to assess the safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single dose of BI 655130 in adult patients with active Generalized Pustular Psoriasis (GPP).

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: BI655130	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Multi-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of BI 655130 in Patients With Active Generalized Pustular Psoriasis.
• Actual Study Start Date: December 19, 2016
• Actual Primary Completion Date: September 20, 2017
• Actual Study Completion Date: January 10, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: BI655130	Drug: BI655130

Outcome Measures

Primary Outcome Measures :

1. Number [N (%)] of patients with adverse reactions defined as drug-related Adverse Events [ Time Frame: Week 8 ]

Secondary Outcome Measures :

1. Percent change from baseline in Generalized Pustular Psoriasis Area and Severity Index total score at Week 2 [ Time Frame: Week 2 ]
2. Proportion of patients with Generalized Pustular Psoriasis Physician Global Assessment total score of 0 (clear) or 1 (almost clear) at Week 2 [ Time Frame: Week 2 ]
3. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue scale score at Week 2 [ Time Frame: Week 2 ]
4. Change from baseline in Pain Visual Analog Scale score at Week 2 [ Time Frame: Week 2 ]
5. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 648 hours ]
6. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 648 hours ]

Eligibility Criteria

• 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, aged 18 to 75 years at screening,
• A known and documented history of Generalized Pustular Psoriasis
• Presenting with a flare of Generalized Pustular Psoriasis
• A Generalized Pustular Psoriasis Physician Global Assessment score of at least moderate severity,
• Generalized Pustular Psoriasis patients receiving maintenance treatment with retinoids and/or methotrexate for at least 4 weeks or Generalized Pustular Psoriasis patients not receiving any maintenance therapy, at screening,
• Signed and dated written informed consent prior to admission to the study,
• Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

Male patients must be ready and able to use condoms.

- Further inclusion criteria apply

Exclusion criteria:

• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgement of the investigator. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress,
• Identified, ongoing serious/severe infection,
• Acute generalized exanthematous pustulosis (AEGP)
• Patient's clinical presentation being considered due to the differential diagnosis of toxic epidermal necrosis or Stevens-Johnson syndrome,
• Currently involved in or intending to participate in another investigational study during the course of this trial,
• Previous enrolment in this trial
• Use of any restricted medication, or any drug considered likely to interfere with the safe conduct of the study
• Background therapy with ciclosporin within the last 30 days preceding the second screening visit,
• Severe, progressive, or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof, as judged by the investigator.
• Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis; QuantiFERON® tuberculosis test will be performed at screening. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines.
• Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).

Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.

• Any documented active or suspected malignancy or history of malignancy within 5 years prior to second screening visit, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
• Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than Generalized Pustular Psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram), or laboratory value at the second screening visit outside the reference range, that is 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,
• Further exclusion criteria apply

Contacts and Locations

Locations

France

HOP Saint-Louis

Paris, France, 75010

Japan

Nagoya City University Hospital

Aichi, Nagoya, Japan, 467-8602

Korea, Republic of

Pusan National Univ. Hosp

Busan, Korea, Republic of, 49241

Malaysia

Hospital Sultanah Aminah

Johor Bahru, Malaysia, 80100

Taiwan

National Taiwan University Hospital

Taipei, Taiwan, 10002

Tunisia

Hedi Chaker Hospital, Department of Dermatology

Tunisia, Tunisia, 1053

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

More Information

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02978690
• Other Study ID Numbers: 1368.11; 2016-001236-35 ( EudraCT Number )
• First Posted: December 1, 2016
• Last Update Posted: January 17, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases