Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne

June 17, 2022 updated by: Novartis Pharmaceuticals

A Randomized, Subject and Investigator Blinded, Placebo-controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne

The study was designed primarily to assess preliminary efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate clinical profile for further clinical development. In addition, sustainability of response and dose relationship were to be explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bonn, Germany, 53111
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Pommelsbrunn, Germany, 91224
        • Novartis Investigative Site
      • Bergen op Zoom, Netherlands, 4624 VT
        • Novartis Investigative Site
      • Groningen, Netherlands, 9713 GZ
        • Novartis Investigative Site
      • Leiden, Netherlands, 2333 CL
        • Novartis Investigative Site
    • California
      • Culver City, California, United States, 90230
        • Novartis Investigative Site
      • Sacramento, California, United States, 95819
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78759
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects aged 18 to 45 years of age included, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening.
  • Body weight between 50 and 120 kg, inclusive at screening.
  • Patients with papulo-pustular acne vulgaris with between 25 and 100 facial inflammatory lesions (papules, pustules and nodules), and presence of non-inflammatory lesions (open and closed comedones) in the face at screening and baseline, who have failed systemic therapy for inflammatory acne.
  • No more than 5 facial inflammatory nodules at screening and baseline.
  • Investigator's Global assessment (IGA) score of at least moderate (3) acne severity on the face at screening and baseline.

Exclusion Criteria:

  • Appropriate wash out periods are required for investigational drugs, any oral/systemic treatment for acne, systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators, any systemic hormonal treatments, previous treatment with biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne treatment.
  • Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
  • Any live vaccines (this includes nasal-spray flu vaccine) starting from 6 weeks before baseline.
  • Any other forms of acne
  • Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
  • History of hypersensitivity or allergy to the investigational compound/compound class being used in this study.
  • Active systemic infections (other than common cold) during the 2 weeks prior to baseline.
  • History of severe systemic Candida infections or evidence of Candidiasis in the 2 weeks prior to baseline.
  • Evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB (Tuberculosis) Gold In-Tube). Patients with evidence of tuberculosis may enter the trial afteradequate treatment has been started according to local regulations.
  • Patients with known active Crohn's disease
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result at screening.
  • A positive Hepatitis B surface antigen or Hepatitis C test result at screening
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human chorionic gonadotropin (HCG) laboratory test.
  • WOCBP, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 13 weeks after stopping medication.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: CJM112 high dose
CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2
Experimental: Group 2: CJM112 low dose
CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2
Placebo Comparator: Group 3: Placebo, CJM112 low dose or high dose
Placebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Inflammatory Facial Lesion Count at Day 85
Time Frame: Day 85
Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Severity of Adverse Events in Period 1
Time Frame: Day 1 to Day 85
Frequency and severity of adverse events in Period 1
Day 1 to Day 85
Number and Severity of Adverse Events in Period 2
Time Frame: Day 86 to Day 260
Frequency and severity of adverse events in Period 2
Day 86 to Day 260
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Time Frame: Day 1, Day 29, Day 57 and Day 85
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Day 1, Day 29, Day 57 and Day 85
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Time Frame: Day 85, Day 113, Day 141 and Day 169
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Day 85, Day 113, Day 141 and Day 169
Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
Time Frame: 38 Weeks
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
38 Weeks
Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
Time Frame: 38 Weeks
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
38 Weeks
Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
Time Frame: 38 Weeks
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
38 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CCJM112X2203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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