A Phase 2 interventional study of ANX005 in Amyotrophic Lateral Sclerosis, sponsored by Annexon, Inc.. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Annexon, Inc. · Phase 2, Interventional, and Treatment
This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.
In this Phase 2a, multi-center, open label, proof-of-biology study, ANX005 will be administered to participants with ALS.
The study consists of approximately 22 weeks of treatment and approximately 14 weeks of follow-up. All participants will be contacted by phone 6 months after study completion.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 17 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Annexon, Inc. is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive induction dosing of ANX005 on Days 1 and 5 or 6, followed by maintenance doses of ANX005 every 2 weeks up to Week 22.
Drug: ANX005
IV Infusion
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Time frame: Up to Week 36
Serum Concentrations of ANX005
Time frame: Up to Week 36
Maximum Observed Serum Concentration (Cmax) of ANX005
Time frame: Up to Week 36
Area Under the ANX005 Serum Concentration-Time Curve
Time frame: Day 1 and Week 22
Change from Baseline in Free Complement (C) 1q Serum Concentrations
Time frame: Baseline, up to Week 36
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Jan 2024, 35 months.
Of 36 industry-sponsored phase 2 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 35. This study's 35 months is above that.
Counting every sponsor, half of 73 studies reached it within 24 months; a quarter within 16 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tanruprubart
Amyotrophic Lateral Sclerosis →
Annexon, Inc.