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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 )

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE December 20, 2016
Results First Submitted Date  ICMJE July 31, 2019
Results First Posted Date  ICMJE October 10, 2019
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE December 22, 2016
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
Total inflammatory facial lesion count at week 12 [ Time Frame: Week 12 ]
Inflammatory facial lesion count
Change History Complete list of historical versions of study NCT02998671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Safety and tolerability as measured by frequency and severity of adverse events [ Time Frame: Week 38 ]
    Frequency and severity of adverse events
  • Pharmacokinetics (PK): Lowest serum concentration observed during a dosing interval during steady state (Cmin,ss) [ Time Frame: Day 1 to Week 38 ]
    Lowest serum concentration observed during a dosing interval at steady state.
  • Safety and tolerability as measured by hematology laboratory parameters [ Time Frame: Week 38 ]
  • Pharmacokinetics (PK): Elimination half life of CJM112 (T1/2) [ Time Frame: Day 1 to Week 38 ]
  • Safety and tolerability as measured by clinical chemistry laboratory paramters [ Time Frame: Week 38 ]
  • Safety and tolerability as measured by urinalysis laboratory paratmeters [ Time Frame: Week 38 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Biological: CJM112
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Group 1: CJM112 high dose
    CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2
    Intervention: Biological: CJM112
  • Experimental: Group 2: CJM112 low dose
    CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2
    Intervention: 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
    Interventions:
    • Biological: CJM112
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
52
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
90
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02998671
Other Study ID Numbers  ICMJE CCJM112X2203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP