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Astegolimab

Phase 3

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Roche Holding AG|Last Updated: Aug 14, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment3,334

FDA Designations

No designations recorded

Clinical trial landscape

Astegolimab · 4 trials · 3 indications

Phase 3 2Phase 2 1Phase 1 1
NCT05878769A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease
ACTIVE NOT_RECRUITING2,000 Analytics
NCT05595642A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD)
ACTIVE NOT_RECRUITING1,290 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of all adverse events (AEs)
Up to 12 weeks after last dose of study treatment
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
52 weeks
Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab
Approximately 85 days
AUC extrapolated to infinity (AUC0-infinity) of astegolimab
Approximately 85 days
Maximum serum concentration (Cmax) of astegolimab
Approximately 85 days

Secondary Endpoints

Time to first moderate or severe COPD exacerbation during the 52-week treatment period
52 weeks
Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score
Week 52
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
Week 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open-Label ExtensionEXPERIMENTALEligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
Astegolimab SC Q2WEXPERIMENTALParticipants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Astegolimab SC Q4WEXPERIMENTALParticipants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Placebo SC Q2WPLACEBO_COMPARATORParticipants will receive SC placebo Q2W
Astegolimab Q2WEXPERIMENTALParticipants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).
Astegolimab Q4WEXPERIMENTALParticipants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
PlaceboPLACEBO_COMPARATORParticipants will receive SC placebo Q2W.
Treatment AEXPERIMENTALParticipants will receive one subcutaneous (SC) dose in the abdomen.
Treatment BEXPERIMENTALParticipants will receive one subcutaneous (SC) dose in the thigh.
Treatment CEXPERIMENTALParticipants will receive one subcutaneous (SC) dose in the upper arm.

Interventions

NameTypeDescription
AstegolimabDRUGParticipants will receive SC astegolimab Q2W
PlaceboDRUGParticipants will receive SC placebo Q2W
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Eligibility Criteria

Age Range40 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites481

Inclusion Criteria: * Completion of the 52-week treatment period in either parent GB43311 or GB44332 Exclusion Criteria: * Withdrawal of consent and/or premature discontinuation from parent study * Any permanent discontinuation of study drug in parent study * Significant non-compliance in the par...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCzechiaDenmarkFranceGermanyGreeceHong KongHungaryIndiaIsraelItalyJapanKenyaLatviaMexicoNetherlandsNew ZealandPeruPhilippinesPolandPuerto RicoRomaniaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

MEDIUMAug 14, 2026NCT05878769Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 14, 2026NCT05878769Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWAug 5, 2026NCT05878769lastUpdatePostDate: changed

Frequently asked questions about Astegolimab

What is Astegolimab used for in COPD?

Astegolimab is an investigational antibody being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is currently in Phase 3 clinical trials for this condition, with studies evaluating its efficacy, safety, and long-term safety in participants with COPD.

What does Astegolimab target?

Astegolimab is a monoclonal antibody, indicated by its -mab suffix. It is being developed by Roche to target pathways involved in COPD. The specific molecular target is not disclosed in the available information, but its mechanism is being evaluated in clinical trials for respiratory disease.

Who makes Astegolimab?

Astegolimab is developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's efficacy and safety in patients with chronic obstructive pulmonary disease (COPD).

What phase is Astegolimab in?

Astegolimab is currently in Phase 3 clinical development for chronic obstructive pulmonary disease (COPD). It has completed a Phase 2 trial and is being evaluated in Phase 3 studies, including a long-term safety study, but it is not yet approved by regulatory authorities.

What clinical trials is Astegolimab in?

Astegolimab is being studied in several clinical trials, including NCT05595642, a Phase 3 study in COPD; NCT05878769, a Phase 3 long-term safety study in COPD; and NCT06462118, a Phase 1 study in healthy volunteers. A Phase 2 trial, NCT05037929, has been completed.

Is Astegolimab the same as other COPD treatments?

Astegolimab is a distinct investigational monoclonal antibody developed by Roche for chronic obstructive pulmonary disease (COPD). It is not identified as being the same as any other named drug in the available information, and its mechanism of action is being studied separately from existing COPD therapies.