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DX-88

Phase 2

Hereditary Angioedema (HAE) | Small molecule | Immunology |Takeda Pharmaceutical Company Limited|Last Updated: May 18, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

DX-88 · 1 trial · 1 indication

Phase 2 1
NCT01826916EDEMA2: Evaluation of DX-88's Effect in Mitigating AngioedemaHereditary Angioedema (HAE)
COMPLETED77 Analytics
PHASE2COMPLETED
EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
Hereditary Angioedema (HAE)Unlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of attacks treated with successful outcome
24 hours

successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours

Proportion of attacks with a partial response
24 hours

partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours

Secondary Endpoints

Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response
24 hours
Time to resolution onset of each acute attack, as determined by patient report
24 hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
5mg/m2 DX-88 IVEXPERIMENTAL5mg/m2 DX-88 (ecallantide)administered intravenously
10mg/m2 DX-88 IVEXPERIMENTAL10mg/m2 DX-88(ecallantide)administered intravenously
20mg/m2 DX-88 IVEXPERIMENTAL20mg/m2 DX-88 (ecallantide) administered intravenously
30 mg DX-88 SCEXPERIMENTAL30mg DX-88(ecallantide)administered subcutaneously

Interventions

NameTypeDescription
DX-88 (ecallantide)DRUGsolution for injection 10 mg/mL
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Eligibility Criteria

Age Range10 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 10 years of age or older * Documented diagnosis of HAE (Type I or II) * Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack * Willing and able to give informed consent Exclusion Criteria: * Patients with a serious i...

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Competitive Landscape -Hereditary Angioedema 9 trials (matched to "Hereditary Angioedema (HAE)")

Frequently asked questions about DX-88

What is DX-88 used for in Hereditary Angioedema (HAE)?

DX-88 is an investigational small molecule being studied for the treatment of Hereditary Angioedema (HAE), a rare genetic condition characterized by recurrent episodes of severe swelling. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes DX-88?

DX-88 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Hereditary Angioedema (HAE).

What phase is DX-88 in?

DX-88 is in Phase 2 clinical development for Hereditary Angioedema (HAE). It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its potential as a treatment.

What clinical trials is DX-88 in?

DX-88 has been evaluated in one completed Phase 2 clinical trial, identified as NCT01826916, titled 'EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema.' This trial enrolled 77 participants with Hereditary Angioedema (HAE) and was a controlled study, though it was not randomized or double-blind.

Is DX-88 the same as any other drug?

DX-88 is not known to have alternative names. It is a distinct investigational small molecule being developed by Takeda Pharmaceutical Company Limited for Hereditary Angioedema (HAE). No other names for this drug have been identified in the available information.