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Psoriasis
P1-IMU-935-CRPC Enrolling

Research Trial for Plaque Psoriasis (98 Days)


Age: 18 Years

Plaque Psoriasis patients (aged 18 to 65) may qualify for this research trial testing an investigational treatment. Eligible participants must have been diagnosed with plaque psoriasis for at least 6 months prior to screening, and have moderate to severe disease involving 10% or more body surface area. Failing to fully respond to or are intolerant to at least one topical therapy for psoriasis, is also required.

Participants will receive investigational oral medication (active study drug) or placebo. Investigational medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 98 days and involve about 7 visits to the study centre.


Official Title

Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

ClinicalTrials.gov ID

NCT05124795

Sponsor

Immunic AG

Study Description

  • Brief Summary:

    Immunic AG

  • Condition or Disease:

    Metastatic Castration Resistant Prostate Cancer

  • Intervention/Treatment:

    Drug: IMU-935 Drug: IMU-935 Drug: IMU-935
  • Phase:

    Phase 1

  • Ages Eligible for Study:

    18 Years and older (Adult,Older Adult)

  • Sexes Eligible for Study:

    Male

Inclusion Criteria:

Age ≥18 years
Male patients with histologically or cytologically confirmed adenocarcinoma of the prostate with no evidence of small cell or neuroendocrine features
Metastatic disease with limited therapeutic options, prior treatment with at least one next-generation hormonal agent (e.g., abiraterone, enzalutamide, apalutamide, darolutamide) and one taxane line of treatment is allowed
Progressive disease is defined as rising prostate-specific antigen (PSA) levels ≥2ng/mL and/or radiographic progression according to Prostate Cancer Working Group 3 (PCWG3) criteria at screening
Able and willing to comply with all study requirements for the duration of the study
Patients must sign an ICF prior to the start of any study-related procedures

Exclusion Criteria:

Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days prior to starting study treatment
Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with the study protocol
Malignancy within the previous 2 years with a ≥30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer or superficial bladder cancer
Patients receiving strong inhibitors or inducers of cytochrome P450 (CYP) 3A4
Chronic use of systemic steroid therapy (>1 month of >10 mg prednisone per day or equivalent, except replacement therapy)
Patients for whom biopsies cannot be taken or are not willing to undergo biopsies
Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at screening


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Kurt Gebauer

Dermatologist

Dr. Lynda Spelman

Dermatologist

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