Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
611 Q2W · 2 trials · 2 indications
FEV1 is the Forced expiratory volume in one second at study site
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
| Arm | Type | Description |
|---|---|---|
| group A | EXPERIMENTAL | 611 300 mg Q2W, subcutaneous (SC) injection |
| group B | EXPERIMENTAL | 611 450 mg Q2W, subcutaneous (SC) injection |
| placebo group | PLACEBO_COMPARATOR | placebo Q2W, subcutaneous (SC) injection |
| 611 Q2W | EXPERIMENTAL | Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q2w from Week 2 to Week 14 (7 cycles). |
| 611 Q4W | EXPERIMENTAL | Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q4w on week 4, 8, 12 and two injections of placebo on week 2, 6, 10, 14. |
| placebo | PLACEBO_COMPARATOR | Four subcutaneous injections of placebo as a loading dose on week 0 Day 1, followed by two injections q2w from Week 2 to Week 14 (7 cycles). |
| Name | Type | Description |
|---|---|---|
| 611 300 mg Q2W | DRUG | 611 subcutaneous (SC) injection |
| 611 450 mg Q2W | DRUG | 611 subcutaneous (SC) injection |
| Matching placebo | DRUG | placebo subcutaneous (SC) injection |
| 611 Q2W | DRUG | subcutaneous injection, 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 2 to Week 14, 7 cycles) |
| 611 Q4W | DRUG | subcutaneous injection, 600mg (loading dose, Day1) + 300mg Q4W (maintenance dose, on week 4, 8, 12) + placebo Q4W (on week 2, 6, 10, 14) |
Inclusion Criteria: 1. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. 2. Male or female adults ages 40 to 85 years old when signing the informed consent. 3. BMI≥16 kg/m2. 4. Documented diagnos...
611 Q2W is an investigational small molecule being developed for atopic dermatitis and chronic obstructive pulmonary disease. It has been evaluated in Chinese adults with moderate to severe atopic dermatitis and in Chinese adults with moderate to severe COPD. The drug is administered every two weeks.
611 Q2W is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The company is conducting clinical trials of 611 Q2W in China for atopic dermatitis and chronic obstructive pulmonary disease.
611 Q2W is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one in atopic dermatitis and one in chronic obstructive pulmonary disease.
611 Q2W has been studied in two completed Phase 2 trials. NCT05544591 evaluated 611 in 93 Chinese adults with moderate to severe atopic dermatitis. NCT06099652 evaluated 611 in 142 Chinese adults with moderate to severe chronic obstructive pulmonary disease. Both trials were randomized, double-blind, and placebo-controlled.
611 Q2W is the name used for the drug in clinical trials, and it is also referred to as 611 in the trial titles. The Q2W designation indicates the dosing frequency of every two weeks. Both names refer to the same investigational drug being developed by Sunshine Biopharma.