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Also known as GS-9688
Selgantolimod · 2 trials · 1 indication
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as any AE with an onset date on or after the first dose date and no later than 30 days after permanent discontinuation of selgantolimod/placebo; or any AE leading to premature discontinuation of study drugs.
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 30 days for selgantolimod/placebo at Week 24. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Clinical laboratory results were graded according to Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.
| Arm | Type | Description |
|---|---|---|
| Selgantolimod 3 mg + TAF | EXPERIMENTAL | Participants with Hepatitis B e antigen (HBeAg)-positive CHB or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, will receive selgantolimod 3 mg (2 x 1.5 mg tablet) on the same day once weekly for 24 doses along with tenofovir alafenamide (TAF) 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks. |
| Selgantolimod 1.5 mg + TAF | EXPERIMENTAL | Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks. |
| Placebo + TAF | PLACEBO_COMPARATOR | Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive 2 tablets of placebo on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, placebo will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks. |
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | EXPERIMENTAL | Participants with Hepatitis B e Antigen (HBeAg)-positive CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks. |
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | EXPERIMENTAL | Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks. |
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | EXPERIMENTAL | Participants with HBeAg-positive CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks. |
| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | EXPERIMENTAL | Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks. |
| Placebo: HBeAg-positive CHB Participants | EXPERIMENTAL | Participants with HBeAg-positive CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks. |
| Placebo: HBeAg-negative CHB Participants | EXPERIMENTAL | Participants with HBeAg-negative CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablet(s) administered orally every 7 days for 24 doses in fasted state |
| Selgantolimod | DRUG | Tablet(s) administered orally every 7 days for 24 doses in fasted state |
| TAF | DRUG | Tablet(s) administered orally once daily with food |
| Hepatitis B virus (HBV) OAV Therapy | DRUG | Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®) |
Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. * Adult male and non-pregnant, non-lactating females * Documented evidence of chronic hepatitis B virus (HBV) infection with detect...
Selgantolimod is an investigational oral therapy being studied for the treatment of chronic hepatitis B virus infection in adults. It is being developed as a potential functional cure approach for patients living with chronic hepatitis B, including both viremic patients not currently on treatment and virally suppressed patients.
Selgantolimod is a small molecule agonist of TLR8, or Toll-like receptor 8. By activating TLR8, it is designed to stimulate innate and adaptive immune responses that may help the body clear hepatitis B virus. This immune-activating mechanism differs from direct-acting antiviral approaches used in chronic hepatitis B.
Selgantolimod is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the drug in chronic hepatitis B.
Selgantolimod is in Phase 2 clinical development for chronic hepatitis B. It is investigational and has not been approved by the FDA. Both of its Phase 2 trials have been completed, and no trials are currently listed as active.
Selgantolimod has been evaluated in two completed Phase 2 trials. NCT03615066 studied viremic adults with chronic hepatitis B not currently on treatment across Canada, South Korea, and Taiwan, enrolling 67 participants. NCT03491553 studied virally suppressed adults with chronic hepatitis B in the United States and New Zealand, enrolling 48 participants. Both were randomized, double-blind, and controlled.
Yes. Selgantolimod was formerly known as GS-9688, and the two names refer to the same Gilead Sciences compound. The earlier GS-9688 designation appears in the title of the Phase 2 trial NCT03615066, which evaluated the drug in viremic adults with chronic hepatitis B.