NCT02442570

A Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple Sclerosis

Completed Phase 2 Last updated 26 August 2015

What this trial tests

Phase 2 trial testing recombinant human alpha B-crystallin in Multiple Sclerosis in 32 participants. Completed in 1 February 2015.

Timeline

1 September 2012

Primary endpoint
1 June 2014

1 February 2015

Quick facts

Lead sponsor	Delta Crystallon BV
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	32
Start date	1 September 2012
Primary completion	1 June 2014
Estimated completion	1 February 2015
Sites	5 locations across Bulgaria

Drugs / interventions tested

• recombinant human alpha B-crystallin — full drug profile →
• Placebo comparator

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Delta Crystallon BV — full company profile →

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety (adverse events)
  Time frame: 48 weeks
  Frequency of adverse events

Sponsor's own description

The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple sclerosis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Intervention in Multiple Sclerosis with Alpha B-Crystallin: A Randomized Controlled Phase IIa Trial.
   van Noort JM, Bsibsi M, Nacken PJ, Verbeek R, et al · · 2015 · cited 45× · PMID 26599332 · DOI 10.1371/journal.pone.0143366
2. HSPB5 suppresses renal inflammation and protects lupus-prone NZB/W F1 mice from severe renal damage.
   Knapp J, Braunstein M, Berg SIT, Shirriff C. · · 2022 · cited 4× · PMID 36510250 · DOI 10.1186/s13075-022-02958-9