Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMG-007 · 3 trials · 4 indications
Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
| Arm | Type | Description |
|---|---|---|
| IMG-007 Dose | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 1 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 2 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 3 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 4 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 5 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 6 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| IMG-007 Dose 7 | EXPERIMENTAL | Subcutaneous injection as per protocol. |
| Placebo Crossover Dose 1 | PLACEBO_COMPARATOR | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
| Placebo Crossover Dose 2 | PLACEBO_COMPARATOR | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
| IMG-007 Dose 1 (300 mg) | EXPERIMENTAL | IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks |
| IMG-007 Dose 2 (600 mg) | EXPERIMENTAL | IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks |
| Name | Type | Description |
|---|---|---|
| IMG-007 | DRUG | Participants will receive IMG-007 subcutaneously. |
| Placebo | DRUG | Participants will receive a placebo subcutaneously. |
Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203
Top 20 of 27 competitors
IMG-007 is an investigational small molecule being developed for Alopecia Areata and Atopic Dermatitis. It is in clinical development and is not yet approved for any indication. ImageneBio, Inc. is studying it in adults with moderate-to-severe Atopic Dermatitis and in adults with Alopecia Areata.
IMG-007 targets OX40, a receptor. OX40 is a co-stimulatory receptor involved in T cell activation and survival, and targeting it is intended to modulate the immune response that drives inflammatory skin conditions such as Alopecia Areata and Atopic Dermatitis. IMG-007 is a small molecule designed to bind this receptor.
IMG-007 is being developed by ImageneBio, Inc., which trades under the ticker IMA. The company is the sponsor of the clinical program evaluating the drug in Alopecia Areata and Atopic Dermatitis.
IMG-007 is in Phase 1 development overall, with Phase 2 trials now underway in Atopic Dermatitis. It is investigational and has not been approved by the FDA. The completed Phase 1 study enrolled 29 adults with Alopecia Areata, and two Phase 2 Atopic Dermatitis studies are currently active.
IMG-007 has been studied in NCT06060977, a completed Phase 1 trial in adult Alopecia Areata participants. Two Phase 2 trials in moderate-to-severe Atopic Dermatitis are active: NCT07037901, which is recruiting in the United States, Australia, Canada and New Zealand, and NCT07734415, which is enrolling by invitation in the United States and Canada.
Across the IMG-007 clinical program, total enrollment is 805 participants. The completed Phase 1 Alopecia Areata study enrolled 29 adults, while the two Phase 2 Atopic Dermatitis trials account for the remainder, with planned enrollment of 405 and 400 participants respectively. All trials enroll adults aged 18 years and older.