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Complement Inhibitor

APL-2 for Cold Agglutinin Disease

Phase 2
Waitlist Available
Research Sponsored by Apellis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 48
Awards & highlights

Study Summary

This trial is to study the effects of a new medication for people with wAIHA or CAD.

Eligible Conditions
  • Cold Agglutinin Disease
  • Autoimmune Hemolytic Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
APL-2 serum concentrations and pharmacokinetic (PK) parameters
Change from baseline in hemoglobin
Total Number of AEs

Side effects data

From 2021 Phase 3 trial • 53 Patients • NCT04085601
13%
Pain in extremity
13%
Hypokalaemia
11%
Arthralgia
11%
Dizziness
9%
Pyrexia
9%
Headache
7%
Ecchymosis
7%
Thrombocytopenia
7%
Erythema
7%
Viral infection
7%
Anaemia
7%
Haemolysis
7%
Musculoskeletal pain
7%
Abdominal pain
7%
Abdominal pain upper
7%
Cough
7%
Epistaxis
7%
Somnolence
7%
Blood creatinine increased
2%
Dyspnoea
2%
Bile duct stone
2%
Septic shock
2%
Oropharyngeal discomfort
2%
Rhinitis allergic
2%
Fatigue
2%
Febrile neutropenia
2%
Neutropenia
2%
Pancytopenia
2%
Dermoid cyst
2%
Upper respiratory tract infection
2%
Hyperuricaemia
2%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Pegcetacoplan
Standard of Care

Trial Design

2Treatment groups
Experimental Treatment
Group I: 270mg or 360mg APL-2 administered subcutaneously daily (wAIHA)Experimental Treatment1 Intervention
Group II: 270mg or 360mg APL-2 administered subcutaneously daily (CAD)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegcetacoplan
FDA approved

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
4,001 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
2017. "Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03226678.
~3 spots leftby Apr 2025
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