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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998671
• Other study ID #: CCJM112X2203
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: June 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Biological:
• CJM112

Other:
• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Pommelsbrunn
Netherlands	Novartis Investigative Site	Bergen op Zoom
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Leiden
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Culver City	California
United States	Novartis Investigative Site	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Inflammatory Facial Lesion Count at Day 85	Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85	Day 85
Secondary	Number and Severity of Adverse Events in Period 1	Frequency and severity of adverse events in Period 1	Day 1 to Day 85
Secondary	Number and Severity of Adverse Events in Period 2	Frequency and severity of adverse events in Period 2	Day 86 to Day 260
Secondary	Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1	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
Secondary	Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2	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
Secondary	Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters	Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.	38 Weeks
Secondary	Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters	Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.	38 Weeks
Secondary	Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters	Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.	38 Weeks