Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998671
Recruitment Status : Terminated (Futility)
First Posted : December 20, 2016
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Biological: CJM112 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 22, 2016
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Group 1: CJM112 high dose
CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2
Biological: CJM112
Experimental: Group 2: CJM112 low dose
CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2
Biological: CJM112
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
Biological: CJM112
Other: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT02998671


Locations
Layout table for location information
United States, California
Novartis Investigative Site
Culver City, California, United States, 90230
Novartis Investigative Site
Sacramento, California, United States, 95819
United States, Texas
Novartis Investigative Site
Austin, Texas, United States, 78759
Germany
Novartis Investigative Site
Bonn, Germany, 53111
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Pommelsbrunn, Germany, 91224
Netherlands
Novartis Investigative Site
Bergen op Zoom, Netherlands, 4624 VT
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site
Leiden, Netherlands, 2333 CL
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] December 14, 2016
Statistical Analysis Plan  [PDF] August 30, 2017


Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02998671     History of Changes
Other Study ID Numbers: CCJM112X2203
First Posted: December 20, 2016    Key Record Dates
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Acne, inflammatory acne, efficacy, safety, PK
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases