Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDP-126 · 5 trials · 1 indication
Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.
The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
During the study, subjects will be assessed for the occurrence of new and ongoing AEs. Descriptions of AEs will include the dates of onset and resolution, maximum severity, seriousness, action taken regarding study drug, corrective treatment, outcome, and investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the subject from the study or requires medical intervention prohibited by the protocol.
| Arm | Type | Description |
|---|---|---|
| IDP-126 Gel | EXPERIMENTAL | - |
| IDP-126 Vehicle Gel | PLACEBO_COMPARATOR | - |
| Epiduo® Forte Gel | ACTIVE_COMPARATOR | Epiduo® Forte Gel (adapalene 0.3%/ 2.5% BPO) applied once daily for 12 weeks |
| IDP-126 Component A | ACTIVE_COMPARATOR | Component A |
| IDP-126 Component B | ACTIVE_COMPARATOR | Component B |
| IDP-126 Component C | ACTIVE_COMPARATOR | Component C |
| Control Gel | ACTIVE_COMPARATOR | Gel |
| Name | Type | Description |
|---|---|---|
| IDP-126 Gel | DRUG | IDP-126 Gel applied topically to the face once daily for 12 weeks. |
| IDP-126 Vehicle Gel | DRUG | IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks. |
| Epiduo® Forte Gel | DRUG | Gel applied to face once daily in the evening. |
| IDP-126 Component A | DRUG | Component A |
| IDP-126 Component B | DRUG | Component B |
| IDP-126 Component C | DRUG | Component C |
| Control Gel | DRUG | gel |
Inclusion Criteria: * Male or female at least 9 years of age and older. * Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent duri...
IDP-126 is an investigational small molecule topical gel being developed for the treatment of acne vulgaris. It is currently in Phase 3 clinical development and has completed five trials with a total enrollment of 1,851 participants. The drug is being studied in patients as young as 9 years old.
IDP-126 is being developed by Bausch Health Companies Inc. (ticker: BHC). The company is conducting clinical trials for this dermatology asset, which is in Phase 3 development for acne vulgaris. Bausch Health has completed five trials for IDP-126 with a total enrollment of 1,851 participants.
IDP-126 is in Phase 3 clinical development for the treatment of acne vulgaris. It is an investigational drug and has not been approved by regulatory authorities. The development program includes completed Phase 1, Phase 2, and Phase 3 trials, with the most advanced studies being Phase 3.
IDP-126 has completed five clinical trials, including NCT03170388 (Phase 2, 741 patients), NCT03653403 (Phase 1, 61 patients), NCT04214652 (Phase 3, 180 patients), and NCT04892706 (Phase 2, 686 patients). All trials were conducted in patients with acne vulgaris, with some including healthy volunteers.
IDP-126 is not the same as Epiduo Forte, but it has been directly compared to Epiduo Forte Gel in a clinical trial. The Phase 2 study NCT04892706 compared the safety and efficacy of IDP-126 Gel to Epiduo Forte Gel and vehicle gel in 686 patients with acne vulgaris.