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

NCT ID: NCT02998671

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-22
• Study Completion Date: 2018-08-01

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: CJM112 high dose

CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2

Group Type: EXPERIMENTAL

CJM112

Intervention Type: BIOLOGICAL

Group 2: CJM112 low dose

CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2

Group Type: EXPERIMENTAL

CJM112

Intervention Type: BIOLOGICAL

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

Group Type: PLACEBO_COMPARATOR

CJM112

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

Interventions

CJM112

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Culver City, California, United States

Novartis Investigative Site

Sacramento, California, United States

Novartis Investigative Site

Austin, Texas, United States

Novartis Investigative Site

Bonn, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Pommelsbrunn, , Germany

Novartis Investigative Site

Bergen op Zoom, , Netherlands

Novartis Investigative Site

Groningen, , Netherlands

Novartis Investigative Site

Leiden, , Netherlands

Countries

United States; Germany; Netherlands

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CCJM112X2203

Identifier Type: -

Identifier Source: org_study_id