Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CJM112 · 4 trials · 4 indications
The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in Liters compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.
Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.
Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events.
| Arm | Type | Description |
|---|---|---|
| CJM112 | EXPERIMENTAL | Study treatment |
| Placebo to CJM112 | PLACEBO_COMPARATOR | Placebo |
| Group 1: CJM112 high dose | EXPERIMENTAL | CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2 |
| Group 2: CJM112 low dose | EXPERIMENTAL | CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2 |
| 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 |
| Period 1: CJM112 High Dose | EXPERIMENTAL | Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses |
| Period 1: Placebo | PLACEBO_COMPARATOR | Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses |
| Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2) | PLACEBO_COMPARATOR | Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on CJM112 High Dose in Period 1 |
| Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2) | EXPERIMENTAL | Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1 |
| Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2) | EXPERIMENTAL | Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1 |
| Placebo | PLACEBO_COMPARATOR | Placebo to match |
| Secukinumab | ACTIVE_COMPARATOR | Active investigational drug. |
| Name | Type | Description |
|---|---|---|
| CJM112 | DRUG | 300 mg CJM112 (Study treatment) s.c. injection received per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment. |
| Placebo to CJM112 | OTHER | Placebo to match CJM112 + standard of care treatment |
| Placebo | OTHER | - |
| Secukinumab | BIOLOGICAL | Monoclonal antibody |
Inclusion Criteria: 1. Patients with a physician-diagnosed history of moderate to severe asthma for a period of at least one year prior to screening. 2. Patients on a stable therapy regimen of asthma for at least 3 months prior to screening with at least medium dose inhaled glucocorticoid and at le...
CJM112 is an investigational monoclonal antibody developed by Novartis AG for inflammatory skin and airway conditions. It has been studied in Phase 2 trials for acne vulgaris, asthma, chronic plaque-type psoriasis, and hidradenitis suppurativa. It is not approved and remains in clinical development.
CJM112 targets IL17A, a pro-inflammatory cytokine. By binding IL17A, the monoclonal antibody is designed to interfere with IL17-driven inflammatory signaling, which is relevant to the inflammatory skin and airway conditions the drug has been studied in.
CJM112 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis sponsored the Phase 1 and Phase 2 clinical studies of the antibody across psoriasis, hidradenitis suppurativa, acne vulgaris, and asthma.
CJM112 is in Phase 2 development. It is an investigational monoclonal antibody and is not FDA approved. Completed studies include a Phase 1 dose escalation trial in psoriasis and Phase 2 trials in asthma, acne vulgaris, and hidradenitis suppurativa.
CJM112 has been evaluated in completed trials including NCT03299686 in severe asthma, NCT02998671 in moderate to severe inflammatory acne, NCT02421172 in hidradenitis suppurativa, and NCT01828086, a Phase 1 dose escalation study in chronic plaque-type psoriasis. These studies enrolled patients across the United States and several European and other countries.
CJM112 was studied in a completed Phase 2 trial, NCT02998671, for moderate to severe inflammatory acne in adults. That randomized, double-blind, placebo-controlled study enrolled 52 patients across the United States, Germany, and the Netherlands. CJM112 is investigational and has not been approved for acne vulgaris.