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A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis

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ClinicalTrials.gov Identifier: NCT03971825
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is a phase 1, randomized, single-center, 3-part, study to assess the safety, tolerability, PK, and PD, of single and multiple doses of CC-92252 in healthy adult subjects and multiple doses of CC-92252 in adult subjects with psoriasis.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Psoriasis Drug: CC-92252 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, 3-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Administration of CC-92252 and Placebo in Healthy Subjects
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoriasis will receive CC-92252 or placebo for up to 12 weeks.
Drug: CC-92252
CC-92252

Other: Placebo
Placebo

Experimental: Administration of CC-92252 and Placebo in Psoriasis subjects
Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoris will receive CC-92252 or placebo for up to 12 weeks.
Drug: CC-92252
CC-92252

Other: Placebo
Placebo




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    Number of participants with adverse event


Secondary Outcome Measures :
  1. Pharmacokinetics - Cmax [ Time Frame: Up to 16 weeks ]
    Observed maximum serum concentration

  2. Pharmacokinetics - AUC0-t [ Time Frame: Up to 16 weeks ]
    Area under the serum concentration-time curve calculated from time zero to the last measured time point

  3. Pharmacokinetics - AUC0-∞ [ Time Frame: Up to 16 weeks ]
    The area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration

  4. Pharmacokinetics - Tmax [ Time Frame: Up to 16 weeks ]
    Time to Cmax

  5. Pharmacokinetics - t1/2z [ Time Frame: UP to 16 weeks ]
    Terminal elimination half-life

  6. Pharmacokinetics - CL/F [ Time Frame: Up to 16 weeks ]
    Apparent clearance of drug from serum after subcutaneous dosing administration

  7. Pharmacokinetics - CL [ Time Frame: Up to 16 weeks ]
    clearance of drug from serum after IV dosing

  8. Pharmacokinetics - Vz/F [ Time Frame: Up to 16 weeks ]
    Apparent volume of distribution during the terminal phase

  9. Pharmacokinetics - Vz [ Time Frame: Up to 16 weeks ]
    Apparent volume of distribution during the terminal phase

  10. Anti-drug Antibody Immunogenicity Anti-drug antibody [ Time Frame: Up to 16 weeks ]
    Evaluation of anti‑CC-92252 antibody formation

  11. Assessment of Pharmacodynamic biomarkers [ Time Frame: UP to 24 weeks ]
    Change in lymphocyte counts



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

Part 1, Part 2, and Part 3

  1. Subject is ≥ 18 and ≤ 55 years (Part 1 and Part 2) and age is ≥ 18 and ≤ 60 years (Part 3) of age at the time of signing the ICF.
  2. Subject has provided informed consent prior to initiation of any study specific activities/procedures
  3. Subject has a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2 (Part 1 and Part 2) and BMI ≥ 18 and ≤ 33 kg/m2 (Part 3), at screening.
  4. Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator.

    Applicable to Part 3 only

  5. Subject has a clinical diagnosis of stable plaque-type PsO at least 6 months prior to screening, defined as:

    BSA ≥ 5% (at both screening and baseline), and sPGA score ≥ 3 (at both screening and baseline)

  6. Must have at least two plaques, at least 3 x 3 centimeters (cm) in diameter. One plaque will be used for punch biopsy and the other for Target Plaque Severity Score (TPSS) evaluation.
  7. Must be in generally good health (except for PsO) as judged by the Investigator
  8. No prior exposure to systemic treatments or biologics for the treatment of psoriasis

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Part 1, Part 2, and Part 3

  1. Subject has any significant medical condition that would prevent the subject from participating in the study.

    a. Part 3 only: This exclusion does not apply to plaque psoriasis

  2. History or presence of cancer
  3. Presence of pre-cancerous conditions
  4. History or presence of a systemic infection or any potentially opportunistic infections
  5. Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  6. Subject has any condition that confounds the ability to interpret data from the study
  7. Subject is pregnant or breastfeeding
  8. Part 1 and Part 2 only: Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer)
  9. Part 1 and Part 2 only: Subject has used any prescribed systemic or topical medication within 30 days prior to the first dose administration.
  10. Part 1 and Part 2 only: Subject has used any non-prescribed systemic or topical medication within 14 days prior to the first dose administration. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to and documented by the Investigator and Sponsor's Medical Monitor.
  11. Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs
  12. Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol screen
  13. Subject is known to have a history of hepatitis B and/or hepatitis C, or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening Note: Subjects who received hepatitis B vaccination and who test positive for hepatitis B surface antibody and negative for both hepatitis B surface antigen and hepatitis B core antibody remain eligible for study participation
  14. Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported)
  15. Vaccination within 30 days prior to the first dose administration or subject has plans to receive a vaccination during the course of the study
  16. Subject has received immunization with a live or live attenuated vaccine within 2 months prior to the first dose administration or is planning to receive immunization with a live or live attenuated vaccine for 2 months following the last dose administration
  17. Subject has a positive QuantiFERON®-TB Gold (or equivalent) TB test at screening or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) TB tests at screening
  18. Subject has a history of incompletely treated Mycobacterium tuberculosis (TB) infection
  19. Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to first dose administration.
  20. Prolonged sun exposure or use of tanning booths Applicable to Part 3 only
  21. Presence of non-plaque psoriasis
  22. Subject has psoriasis flare within 4 weeks before screening
  23. Presence of dermatological diseases other than plaque psoriasis
  24. Presence of Psoriatic Arthritis
  25. Use of topical therapy for psoriasis within 14 days of first dosing (including but not limited to corticosteroids, retinoids, vitamin D analog, calcineurin inhibitors, salicylic acid) Exceptions: low potency topical corticosteroids will be allowed as background therapy for treatment of psoriatic lesions of the face, axillae and groin in accordance with the manufacturers' suggested usage; subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions; Eucerin® cream (the standard emollient for this study; or equivalent) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to each clinic visit.
  26. Use of systemic therapy for psoriasis within 30 days of first dose administration
  27. Use of phototherapy for psoriasis within 30 days of first dose administration
  28. Use of systemic biologic treatment within 24 weeks of first dose administration
  29. Exposure to an immunosuppressive or immunomodulatory drug within 30 days of first dose administration, or five half-lives of the drug (whichever is longer)
  30. Exposure to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer)

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): NCT03971825


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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Germany
Charite Research Organisation GmBH Recruiting
Berlin, Germany, 10117
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Francisco Ramirez-Valle, MD, PhD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03971825     History of Changes
Other Study ID Numbers: CC-92252-CP-001
U1111-1229-5867 ( Registry Identifier: WHO )
2018-001050-10 ( EudraCT Number )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Celgene:
Psoriasis
Healthy Volunteer
Safety
CC-92252
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases