BI655130 Single Dose in Generalized Pustular Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02978690
• Date of registration: 29/11/2016
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: BI655130 Single Dose in Generalized Pustular Psoriasis
• Scientific 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.
• Date of first enrolment: December 19, 2016
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02978690
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, Japan, Korea, Republic of, Malaysia, Singapore, Taiwan, Tunisia

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: BI655130

Primary Outcome(s)

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

Secondary Outcome(s)

Change from baseline in Pain Visual Analog Scale score at Week 2 [Time Frame: Week 2]

Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue scale score at Week 2 [Time Frame: Week 2]

AUC0-8 (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]

Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 648 hours]

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]

Percent change from baseline in Generalized Pustular Psoriasis Area and Severity Index total score at Week 2 [Time Frame: Week 2]

Secondary ID(s)

1368.11

2016-001236-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors