Acne Vulgaris
Conditions
Keywords
Acne, inflammatory acne, efficacy, safety, PK
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.
Interventions
BIOLOGICALCJM112
OTHERPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Inflammatory Facial Lesion Count at Day 85 | Day 85 | Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Severity of Adverse Events in Period 2 | Day 86 to Day 260 | Frequency and severity of adverse events in Period 2 |
| 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. Concentrations below the lower limit of quantification were reported as 0. |
| Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | 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 and Severity of Adverse Events in Period 1 | Day 1 to Day 85 | Frequency and severity of adverse events in Period 1 |
| Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | 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 | 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 Hematology Laboratory Parameters | 38 Weeks | Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects. |
Countries
Germany, Netherlands, United States
Participant flow
Recruitment details
A total of approximately 75 subjects were planned to be enrolled in the study. The study was terminated early due to futility after a total of 52 subjects were enrolled and randomized.
Pre-assignment details
For period 1 (12 weeks) subjects were randomized to one of the 3 treatment groups CJM112 high dose, CJM112 low dose or placebo. For Period 2 (12 weeks) subjects treated with Placebo in Period 1 were rerandomized to CJM112 high dose or CJM112 low dose. All other subjects remained on the same dose.
Participants by arm
| Arm | Count |
|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169) | 21 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169) | 13 |
| P1: Placebo / P2: CJM112 High Dose Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169) | 6 |
| P1: Placebo / P2: CJM112 Low Dose Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169) | 8 |
| P1: Placebo / P2: NA Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2 | 4 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Period 1 | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Period 1 | Pregnancy | 1 | 0 | 0 | 0 | 0 |
| Period 1 | Study Terminated By Sponsor | 2 | 1 | 0 | 0 | 1 |
| Period 1 | Withdrawal by Subject | 1 | 2 | 0 | 0 | 2 |
| Period 2 | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Period 2 | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Period 2 | Study Terminated By Sponsor | 3 | 5 | 1 | 3 | 0 |
| Period 2 | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | P1: CJM112 High Dose / P2: CJM112 High Dose | P1: CJM112 Low Dose / P2: CJM112 Low Dose | P1: Placebo / P2: CJM112 High Dose | P1: Placebo / P2: CJM112 Low Dose | P1: Placebo / P2: NA | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 23.8 years STANDARD_DEVIATION 4.19 | 25.5 years STANDARD_DEVIATION 5.99 | 22.5 years STANDARD_DEVIATION 3.21 | 25 years STANDARD_DEVIATION 4.66 | 23.75 years STANDARD_DEVIATION 4.35 | 24.3 years STANDARD_DEVIATION 4.62 |
| Race/Ethnicity, Customized Other | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 10 Participants | 5 Participants | 8 Participants | 4 Participants | 45 Participants |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 3 Participants | 6 Participants | 4 Participants | 34 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 3 Participants | 2 Participants | 0 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 13 | 0 / 18 | 0 / 34 | 0 / 17 | 0 / 10 | 0 / 6 | 0 / 8 | 0 / 23 | 0 / 18 |
| other Total, other adverse events | 16 / 21 | 11 / 13 | 10 / 18 | 27 / 34 | 10 / 17 | 9 / 10 | 5 / 6 | 5 / 8 | 15 / 23 | 14 / 18 |
| serious Total, serious adverse events | 0 / 21 | 0 / 13 | 0 / 18 | 0 / 34 | 1 / 17 | 0 / 10 | 0 / 6 | 0 / 8 | 1 / 23 | 0 / 18 |
Outcome results
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
Time frame: Day 85
Population: Pharmacodynamic analysis set, including only patients completing 12-week assessments.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Total Inflammatory Facial Lesion Count at Day 85 | 21.9 Lesions |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Total Inflammatory Facial Lesion Count at Day 85 | 20.3 Lesions |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Total Inflammatory Facial Lesion Count at Day 85 | 18.5 Lesions |
90% CI: [0.79, 1.81]Bayesian model for repeated measurements
90% CI: [0.66, 1.8]Bayesian model for repeated measurements
Secondary
Number and Severity of Adverse Events in Period 1
Frequency and severity of adverse events in Period 1
Time frame: Day 1 to Day 85
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of moderate intensity | 5 Adverse Events |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of mild intensity | 27 Adverse Events |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of severe intensity | 0 Adverse Events |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of moderate intensity | 7 Adverse Events |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of mild intensity | 25 Adverse Events |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of severe intensity | 1 Adverse Events |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of mild intensity | 20 Adverse Events |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of severe intensity | 0 Adverse Events |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number and Severity of Adverse Events in Period 1 | Number of AEs of moderate intensity | 9 Adverse Events |
Secondary
Number and Severity of Adverse Events in Period 2
Frequency and severity of adverse events in Period 2
Time frame: Day 86 to Day 260
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of mild intensity | 21 Adverse Events |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of severe intensity | 1 Adverse Events |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of moderate intensity | 6 Adverse Events |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of mild intensity | 20 Adverse Events |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of severe intensity | 1 Adverse Events |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of moderate intensity | 1 Adverse Events |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of moderate intensity | 3 Adverse Events |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of mild intensity | 6 Adverse Events |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of severe intensity | 0 Adverse Events |
| P1: Placebo / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of mild intensity | 13 Adverse Events |
| P1: Placebo / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of severe intensity | 0 Adverse Events |
| P1: Placebo / P2: CJM112 Low Dose | Number and Severity of Adverse Events in Period 2 | Number of AEs of moderate intensity | 1 Adverse Events |
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.
Time frame: 38 Weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 2 | 0 Participants |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 1 | 3 Participants |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 1 | 0 Participants |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 2 | 3 Participants |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 2 | 1 Participants |
| P1: Placebo / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 2 | 1 Participants |
| P1: Placebo / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2: NA | Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Period 1 | 0 Participants |
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.
Time frame: 38 Weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 1 | 0 Participants |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 2 | 0 Participants |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 2 | 0 Participants |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 2 | 0 Participants |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 2 | 0 Participants |
| P1: Placebo / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2: NA | Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Period 1 | 0 Participants |
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.
Time frame: 38 Weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 1 | 0 Participants |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 2 | 0 Participants |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 2 | 0 Participants |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 2 | 0 Participants |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 2 | 0 Participants |
| P1: Placebo / P2: CJM112 Low Dose | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 1 | 0 Participants |
| P1: Placebo / P2: NA | Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Period 1 | 0 Participants |
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.
Time frame: Day 1, Day 29, Day 57 and Day 85
Population: Pharmacokinetic analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 1 (Pre Dose) | 152 ng/mL | Standard Deviation 663 |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 29 (Pre Dose) | 8670 ng/mL | Standard Deviation 3370 |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 57 (Pre Dose) | 11500 ng/mL | Standard Deviation 5020 |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 85 (Pre Dose) | 17000 ng/mL | Standard Deviation 8080 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 85 (Pre Dose) | 2040 ng/mL | Standard Deviation 1570 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 1 (Pre Dose) | 0 ng/mL | Standard Deviation 0 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 57 (Pre Dose) | 1550 ng/mL | Standard Deviation 1130 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Period 1 Day 29 (Pre Dose) | 802 ng/mL | Standard Deviation 961 |
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.
Time frame: Day 85, Day 113, Day 141 and Day 169
Population: Pharmacokinetic analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 85 (Pre Dose) | 17000 ng/mL | Standard Deviation 8080 |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 141 (Pre Dose) | 18700 ng/mL | Standard Deviation 9450 |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 169 (Pre Dose) | 19400 ng/mL | Standard Deviation 9650 |
| P1: CJM112 High Dose / P2: CJM112 High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 113 (Pre Dose) | 15900 ng/mL | Standard Deviation 8140 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 85 (Pre Dose) | 2040 ng/mL | Standard Deviation 1570 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 113 (Pre Dose) | 1890 ng/mL | Standard Deviation 634 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 169 (Pre Dose) | 3890 ng/mL | Standard Deviation 1890 |
| P1: CJM112 Low Dose / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 141 (Pre Dose) | 3140 ng/mL | Standard Deviation 2180 |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 113 (Pre Dose) | 8260 ng/mL | Standard Deviation 5120 |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 141 (Pre Dose) | 15700 ng/mL | Standard Deviation 10700 |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 169 (Pre Dose) | 16600 ng/mL | Standard Deviation 6610 |
| P1: Placebo / P2 CJM112 Low Dose or High Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 85 (Pre Dose) | 713 ng/mL | Standard Deviation 1750 |
| P1: Placebo / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 85 (Pre Dose) | 0 ng/mL | Standard Deviation 0 |
| P1: Placebo / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 141 (Pre Dose) | 3700 ng/mL | Standard Deviation 1250 |
| P1: Placebo / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 113 (Pre Dose) | 1430 ng/mL | Standard Deviation 1190 |
| P1: Placebo / P2: CJM112 Low Dose | Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Period 2 Day 169 (Pre Dose) | 2890 ng/mL | Standard Deviation 672 |