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

NCT02998671 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CCJM112X2203
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 10

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

Keywords

Acne, inflammatory acne, efficacy, safety, PK

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number and Severity of Adverse Events in Period 1

  Day 1 to Day 85

• Number and Severity of Adverse Events in Period 2

  Day 86 to Day 260

• Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1

  Day 1, Day 29, Day 57 and Day 85

• Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2

  Day 85, Day 113, Day 141 and Day 169

• Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters

  38 Weeks

Study Arms (3)

Group 1: CJM112 high dose

EXPERIMENTAL

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

Biological: CJM112

Group 2: CJM112 low dose

EXPERIMENTAL

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

Biological: CJM112

Group 3: Placebo, CJM112 low dose or high dose

PLACEBO COMPARATOR

Placebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2

Biological: CJM112; Other: Placebo

Interventions

CJM112 BIOLOGICAL

Group 1: CJM112 high dose; Group 2: CJM112 low dose; Group 3: Placebo, CJM112 low dose or high dose

Placebo OTHER

Group 3: Placebo, CJM112 low dose or high dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Culver City, California, 90230, United States

Location

Novartis Investigative Site

Sacramento, California, 95819, United States

Location

Novartis Investigative Site

Austin, Texas, 78759, United States

Location

Novartis Investigative Site

Bonn, 53111, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Pommelsbrunn, 91224, Germany

Location

Novartis Investigative Site

Bergen op Zoom, 4624 VT, Netherlands

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

Novartis Investigative Site

Leiden, 2333 CL, Netherlands

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 20, 2016
• Study Start: December 22, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 12, 2022
• Results First Posted: October 10, 2019

Record last verified: 2022-06

Locations

US (3); DE (4); NL (3)