Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CC-90006 in Subjects With Mild to Moderate Plaque-type Psoriasis

NCT03337022 | Completed Phase 1 FDA Drug

• 1 other identifier: CC-90006-CP-002
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 4

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis; CC-90006; Mild to moderate plaque-type psoriasis; Safety; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with adverse events

  Up to approximately Week 20

Secondary Outcomes (9)

• Pharmacokinetics: Cmax

  Up to approximately 16 weeks

• Pharmacokinetics - Tmax

  Up to approximately 16 weeks

• Pharmacokinetics - AUC 0-t

  Up to approximately 16 weeks

• Pharmacokinetics - AUC 0-∞

  Up to approximately 16 weeks

• Pharmacokinetics - t1/2

  Up to approximately 16 weeks

Study Arms (5)

CC-90006; Dose level 1

EXPERIMENTAL

CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.

Drug: CC-90006

CC-90006; Dose level 2

EXPERIMENTAL

CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.

Drug: CC-90006

CC-90006; Dose level 3

EXPERIMENTAL

CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.

Drug: CC-90006

CC-90006; Dose level 4

EXPERIMENTAL

CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.

Drug: CC-90006

Placebo

PLACEBO COMPARATOR

Placebo (saline) will be administered subcutaneously (SC) on days 1, 15, and 29.

Other: Placebo

Interventions

CC-90006 DRUG

CC-90006

CC-90006; Dose level 1; CC-90006; Dose level 2; CC-90006; Dose level 3; CC-90006; Dose level 4

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males or non-pregnant females between the ages of 18 and 60 years (inclusive) at the time of signing the ICF, and be willing to adhere to the requirements of contraception use throughout the study.
• Female subjects who claim to be surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) must have undergone the procedure at least 6 months before screening,
• Females who claim to be postmenopausal (defined as 24 consecutive months without menses before screening, should have a confirmed follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening).
• All other females must:
• i. Have two negative pregnancy tests (at screening and baseline) as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
• ii. Either commit to true abstinence from heterosexual contact or agree to use two forms of reliable contraception simultaneously. One must be a highly effective method and one additional effective (barrier) method, and both must be practiced without interruption, 28 days prior to starting investigational product, during the study therapy (including dose interruptions), and for 4 months after discontinuation of study therapy.
• d. Males must practice true abstinence1 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \[animal\] membrane \[latex condoms are recommended\]) during sexual contact with a pregnant female or FCBP2 while participating in the study, during dose interruptions, and for at least 4 months after the last dose of IP, even if he has undergone a successful vasectomy.
• Must be diagnosed with mild to moderate plaque-type psoriasis at least 6 months prior to baseline (Day 1).
• Must have a PASI ≤ 15 at screening and baseline (Day 1).
• Must have a body surface area affected score (BSA) ≥ 1 and sPGA ≥ 3 at screening and baseline (Day 1).
• 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 TPSS evaluation.
• Other than the diagnosed condition of mild to moderate plaque-type psoriasis, the subject must be in good health as determined by a physical examination (PE) at screening.
• Has a body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening.
• For all other clinical laboratory safety test parameters, the subject has results within normal limits or judged to be not clinically significant by the Investigator.

You may not qualify if:

• Presence of any significant medical condition, laboratory abnormality, or psychiatric illness which places him or her at unacceptable risk by participating in the study, or that would that would prevent the subject from participating in the study for other reasons, or would confound the ability to interpret data from the study.
• History of cancer.
• Presence of cancer or pre-cancerous conditions,
• Presence of confirmed cervical dysplasia.
• Presence of a systemic infection or any potentially opportunistic infections (eg, atypical mycobacterial, CMV, Clostridium difficile, multifocal herpetic, etc).
• Presence of latent tuberculosis infection and/or active tuberculosis disease, as tested using QuantiFERON-TB Gold test (or equivalent). Subjects with a history of TB who have completed treatment (documented) may be eligible for the study.
• History of serum hepatitis, or a confirmed carrier of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcA), or hepatitis C virus antibody (HCV Ab), or who has a positive HIV antibody test.
• Presence of non-plaque psoriasis (erythrodermic, guttate, inverse, or pustular psoriasis).
• Presence of dermatological diseases other than plaque psoriasis, including but not limited to seborrheic dermatitis, lichen simplex chronicus, atopic dermatitis, nummular eczema, superficial fungal infections, subacute cutaneous lupus erythematosus, pityriasis rubra pilaris, crusted scabies, cutaneous T cell lymphoma
• 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).
• Use of systemic therapy for psoriasis within 30 days of first dose administration.
• Use of phototherapy for psoriasis within 30 days of first dose administration.
• Use of systemic biologics treatment for psoriasis within 24 weeks of first dose administration.
• Exposure to an immunosuppressive or immunomodulatory drug within 30 days of first dose administration, or five half-lives of the drug (whichever is longer).
• 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).

Sponsors & Collaborators

• Celgene: lead

Study Sites (4)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Innovaderm Research

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Leon Carayannopoulos, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 8, 2017
• Study Start: January 4, 2018
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)