AzTrials
AzTrials

Healthy VolunteersPhase 1NCT03971825

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

A Phase 1 study testing CC-92252 in people with Healthy Volunteers and Psoriasis, run by Celgene at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Psoriasis
What is being tested?
CC-92252
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
1 siteGermany
Study dates
24 Jul 2018to 5 Aug 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Part 1, Part 2, and Part 3
  • 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.
  • Subject has provided informed consent prior to initiation of any study specific activities/procedures
  • 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.
  • Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator.
Show all 12Show fewer
  • Applicable to Part 3 only
  • 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)
  • 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.
  • Must be in generally good health (except for PsO) as judged by the Investigator
  • No prior exposure to systemic treatments or biologics for the treatment of psoriasis

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • Part 1, Part 2, and Part 3
  • Subject has any significant medical condition that would prevent the subject from participating in the study.
  • Part 3 only: This exclusion does not apply to plaque psoriasis
  • History or presence of cancer
  • Presence of pre-cancerous conditions
Show all 33Show fewer
  • History or presence of a systemic infection or any potentially opportunistic infections
  • 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
  • Subject has any condition that confounds the ability to interpret data from the study
  • Subject is pregnant or breastfeeding
  • 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)
  • Part 1 and Part 2 only: Subject has used any prescribed systemic or topical medication within 30 days prior to the first dose administration.
  • 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.
  • 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
  • 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
  • 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
  • Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported)
  • Vaccination within 30 days prior to the first dose administration or subject has plans to receive a vaccination during the course of the study
  • 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
  • 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
  • Subject has a history of incompletely treated Mycobacterium tuberculosis (TB) infection
  • 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.
  • Prolonged sun exposure or use of tanning booths Applicable to Part 3 only
  • Presence of non-plaque psoriasis
  • Subject has psoriasis flare within 4 weeks before screening
  • Presence of dermatological diseases other than plaque psoriasis
  • Presence of Psoriatic Arthritis
  • 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.
  • 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 biologic treatment 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charite Research Organisation GmbH

    Berlin, 10117

Other trials in Germany

About this study

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.

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.

Being tested
CC-92252, Placebo
Keywords
Psoriasis, Healthy Volunteer, Safety, CC-92252
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-92252Drug

    CC-92252

  • PlaceboOther

    Placebo

Study groups in NCT03971825
Study groupRoleWhat they receive
Administration of CC-92252 and Placebo in Healthy SubjectsExperimentalPart 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.
Receives: Drug: CC-92252; Other: Placebo
Administration of CC-92252 and Placebo in Psoriasis subjectsExperimentalPart 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.
Receives: Drug: CC-92252; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    Number of participants with adverse event

    Measured: From enrollment until at least 28 days after completion of study treatment

Secondary outcomes (11)

  1. Pharmacokinetics - Cmax

    Observed maximum serum concentration

    Measured: Up to 16 weeks

  2. Pharmacokinetics - AUC0-t

    Area under the serum concentration-time curve calculated from time zero to the last measured time point

    Measured: Up to 16 weeks

  3. Pharmacokinetics - AUC0-∞

    The area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration

    Measured: Up to 16 weeks

  4. Pharmacokinetics - Tmax

    Time to Cmax

    Measured: Up to 16 weeks

  5. Pharmacokinetics - t1/2z

    Terminal elimination half-life

    Measured: UP to 16 weeks

  6. Pharmacokinetics - CL/F

    Apparent clearance of drug from serum after subcutaneous dosing administration

    Measured: Up to 16 weeks

  7. Pharmacokinetics - CL

    clearance of drug from serum after IV dosing

    Measured: Up to 16 weeks

  8. Pharmacokinetics - Vz/F

    Apparent volume of distribution during the terminal phase

    Measured: Up to 16 weeks

  9. Pharmacokinetics - Vz

    Apparent volume of distribution during the terminal phase

    Measured: Up to 16 weeks

  10. Anti-drug Antibody Immunogenicity Anti-drug antibody

    Evaluation of anti-CC-92252 antibody formation

    Measured: Up to 16 weeks

  11. Assessment of Pharmacodynamic biomarkers

    Change in lymphocyte counts

    Measured: UP to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start24 Jul 2018
  3. Primary completion5 Aug 2021
  4. Study completion5 Aug 2021

Why it stopped: Did not meet progression criteria

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03971825
Sponsor's protocol ID
CC-92252-CP-001
Other IDs
U1111-1229-5867, 2018-001050-10, 2018
Status last verified
Aug 2021
First submitted
31 May 2019
Last updated
30 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-92252 in people with Healthy Volunteers and Psoriasis, run by Celgene at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Did not meet progression criteria). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: From enrollment until at least 28 days after completion of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03971825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in